Issued: London, UK – LSE Announcement
\nGlaxoSmithKline (LSE/NYSE: GSK) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in paediatric patients aged six up to 17 years. If approved it would be the first targeted biologic therapy for the treatment of severe eosinophilic asthma in paediatric patients in Europe.
\nDr Hal Barron, Chief Scientific Officer and President, R&D GSK said: “Ensuring our medicines have the broadest possible label is very important, as it allows us to help the greatest number of patients who may benefit. If approved Nucala could provide an additional option for younger patients in Europe who still struggle to control their asthma despite taking inhaled steroids and other controller medications. These are patients who are at high risk of asthma attacks, which can be a very frightening experience for anyone, especially young children.”
\nAsthma is the commonest chronic disease in childhood and severe asthma that is poorly responsive to current standard of care asthma treatments has been reported in approximately 4.5% of children with asthma.1
\nA CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission.
\nAbout severe asthma and eosinophilic inflammation
\nSevere asthma is defined as asthma which requires treatment with high dose inhaled corticosteroids (ICS) plus a second controller (and/or systemic corticosteroids) to prevent it from becoming ‘uncontrolled’ or which remains ‘uncontrolled’ despite this therapy. Severe asthma patients are also often categorised by long-term use of oral corticosteroids (OCS). In a sub-set of severe asthma patients, the over-production of eosinophils (a type of white blood cell) is known to cause inflammation in the lungs that can affect the airways, limiting breathing and increasing the frequency of asthma attacks. Interleukin-5 (IL-5) is the main promoter of eosinophil growth, activation and survival and provides an essential signal for the movement of eosinophils from the bone marrow into the lung.
\nAbout Nucala (mepolizumab)
\nMepolizumab is the first-in-class monoclonal antibody that targets IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of white blood cells called eosinophils. Inhibiting IL-5 binding in this way reduces blood eosinophils.
\nMepolizumab has been developed for the treatment of diseases that are driven by inflammation caused by eosinophils. It has been approved (under the brand name Nucala) in the US, Europe and in over 20 other markets, as an add-on maintenance treatment for patients with severe eosinophilic asthma and is the leading biologic in this indication. In the US, Japan and Canada it is approved as add-on maintenance treatment for patients with eosinophilic granulomatosis with polyangiitis (EGPA).
\nThis paediatric licence application is supported by a partial extrapolation approach agreed with the EU Paediatric Committee of the European Medicines Agency which utilised the efficacy and safety data available in paediatric patients and its well-documented positive benefit to risk profile in adult patients. Existing data was used from adolescent participants in the mepolizumab severe asthma pivotal programme in addition to new data from children in the pharmacokinetic (PK)/ pharmacodynamic (PD) study 200363. Part A, completed in children 6-11 years old with severe eosinophilic asthma, collected uncontrolled safety and limited efficacy data and showed that subcutaneous PK data in children 6 to 11 years is consistent with adults after adjustment for bodyweight and bioavailability and that mepolizumab blood eosinophil count reduction in adults is predictive of the blood eosinophil count reduction in paediatric patients. The safety profile of mepolizumab in children and adolescents with severe asthma appears similar to that of adolescents and adults from the Phase III placebo controlled severe eosinophilic asthma studies. No new safety concerns were identified for paediatrics when compared with the overall adolescent and adult data from the Phase III placebo controlled severe eosinophilic asthma studies.
\nThe adult application was supported with data from the mepolizumab phase II/III clinical development programme, which involved nine studies and a total of 915 patients with severe refractory eosinophilic asthma. Patients received either a subcutaneous or an intravenous dose of mepolizumab during clinical studies of 24 to 52 weeks duration. Three key clinical trials – DREAM (MEA112997), MENSA (MEA115588) and SIRIUS (MEA115575) – have established the efficacy and safety profile of Nucala for severe refractory eosinophilic asthma patients.
\nThe European Marketing Authorisation Application for Nucala in patients over 18 was submitted to the EMA on 21 November 2014 and was approved on 2 December 2015.
\nGSK’s commitment to respiratory disease
\nGSK has led the way in developing innovative medicines to advance the management of asthma and COPD for nearly 50 years. Over the last five years we have launched six innovative medicines responding to continued unmet patient need, despite existing therapies. This is an industry leading portfolio in breadth, depth and innovation, developed to reach the right patients, with the right treatment.
\nImportant Safety Information for Nucala
\nThe following Important Safety Information is based on a summary of the European Summary of Product Characteristics and Prescribing Information for Nucala in patients 18 and over. Please consult the full Summary of Product Characteristics and Prescribing Information for all the safety information for Nucala.
\nNucala is contraindicated in patients with hypersensitivity to mepolizumab or to any of the excipients.
\nNucala should not be used to treat acute asthma exacerbations.
\nAsthma-related adverse events or exacerbations may occur during treatment. Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment.
\nAbrupt discontinuation of corticosteroids after initiation of Nucala therapy is not recommended. Reduction in corticosteroid doses, if required, should be gradual and performed under the supervision of a physician.
\nAcute and delayed systemic reactions, including hypersensitivity reactions (e.g. anaphylaxis, urticaria, angioedema, rash, bronchospasm, hypotension), have occurred following administration of Nucala. These reactions generally occur within hours of administration, but in some instances have a delayed onset (i.e., typically within several days). These reactions may occur for the first time after a long duration of treatment.
\nHerpes zoster has occurred in subjects receiving Nucala in controlled clinical trials. Consider vaccination if medically appropriate.
\nEosinophils may be involved in the immunological response to some helminth infections. Patients with pre-existing helminth infections should be treated for the helminth infection before starting therapy with Nucala. If patients become infected whilst receiving treatment with Nucala and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
\nIn clinical studies in subjects with severe refractory eosinophilic asthma, the most commonly reported adverse reactions during treatment were headache, injection site reactions and back pain. Headache was considered very common, occurring with a frequency of ≥1/10. Common adverse drug reactions (≥1/100 to <1/10) included: lower respiratory tract infection, urinary tract infection, pharyngitis, hypersensitivity reactions (systemic, allergic), nasal congestion, upper abdominal pain, eczema, back pain, administration-related reaction (systemic, non-allergic), local injection site reactions, and pyrexia.
\nInjection site reactions (e.g., pain, erythema, swelling, itching, and burning sensation) occurred at a rate of 8% in subjects treated with Nucala compared with 3% in subjects treated with placebo.
\nGSK - a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit about us.
\nTrademarks are owned by or licensed to the GSK group of companies.
\nCautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D Principal risks and uncertainties in the company's Annual Report on Form 20-F for 2017.
","useGreyBackground":false,"fullWidth":false}]},"id":7255,"docCheckLogout":null,"pageType":"pressReleasePage","languageCode":"en-GB","theme":"light","breadcrumb":{"ariaLabel":"Breadcrumb","links":[{"text":"Home","href":"/en-gb/","openInNewWindowText":null},{"text":"Media","href":"/en-gb/media/","openInNewWindowText":null},{"text":"Press releases","href":"/en-gb/media/press-releases/","openInNewWindowText":null},{"text":"CHMP recommend Nucala (mepolizumab) for the treatment of severe eosinophilic asthma paediatric patients in Europe","href":"/en-gb/media/press-releases/chmp-recommend-nucala-mepolizumab-for-the-treatment-of-severe-eosinophilic-asthma-paediatric-patients-in-europe/","openInNewWindowText":null}]},"pageName":"CHMP recommend Nucala (mepolizumab) for the treatment of severe eosinophilic asthma paediatric patients in Europe","topNav":{"homeLink":{"text":"GSK Homepage","href":"/en-gb/","openInNewWindowText":null},"topBar":{"currentLocation":{"isGlobal":true,"text":"Global"},"languageSelector":{"currentLanguage":null,"currentLanguageMobile":null,"selectableLanguages":[]},"darkModeSwitch":{"text":"Dark mode","tooltipText":"Switch to dark mode to head towards a more sustainable world together. More info
"},"globalSiteLink":null,"locationSelector":{"text":"Change location","href":"/en-gb/locations/","openInNewWindowText":null},"healthCareLink":{"text":"Healthcare professionals","href":"https://www.gskpro.com","target":"_blank","openInNewWindowText":"Opens in a new window"},"contactUs":{"text":"Contact us","href":"/en-gb/contact-us/","openInNewWindowText":null},"search":"Search","backToMain":"Back to main","menu":"Menu","closeMenu":"Close menu","animationsToggleModel":{"enable":true,"activeText":"Pause video","inactiveText":"Play video"}},"nodes":[{"tooltip":null,"hasBorderRight":true,"title":"Behind the Science magazine","url":"/en-gb/behind-the-science-magazine/","nodes":[],"isActive":false,"promos":[]},{"tooltip":null,"hasBorderRight":false,"title":"Company","url":"/en-gb/company/","nodes":[{"title":"Purpose, strategy and culture","url":"/en-gb/company/purpose-strategy-and-culture/","nodes":[],"isActive":false},{"title":"Outstanding people","url":"/en-gb/company/outstanding-people/","nodes":[{"title":"Great place to work","url":"/en-gb/company/outstanding-people/great-place-to-work/","nodes":[],"isActive":false},{"title":"Meet our veterans","url":"/en-gb/company/outstanding-people/meet-our-veterans/","nodes":[],"isActive":false},{"title":"Working together","url":"/en-gb/company/outstanding-people/working-together/","nodes":[],"isActive":false},{"title":"My GSK story","url":"/en-gb/company/outstanding-people/my-gsk-story/","nodes":[],"isActive":false},{"title":"Innovating together","url":"/en-gb/company/outstanding-people/innovating-together/","nodes":[],"isActive":false}],"isActive":false},{"title":"GSK at a glance","url":"/en-gb/company/gsk-at-a-glance/","nodes":[],"isActive":false},{"title":"History and heritage","url":"/en-gb/company/history-and-heritage/","nodes":[],"isActive":false},{"title":"Board of Directors and Executive Committee","url":"/en-gb/company/board-of-directors-and-leadership-team/","nodes":[],"isActive":false},{"title":"Board information","url":"/en-gb/company/board-information/","nodes":[],"isActive":false},{"title":"Governance","url":"/en-gb/company/governance/","nodes":[{"title":"Committees","url":"/en-gb/company/governance/committees/","nodes":[],"isActive":false},{"title":"Shareholders","url":"/en-gb/company/governance/shareholders/","nodes":[],"isActive":false},{"title":"Sarbanes-Oxley Act 2002","url":"/en-gb/company/governance/sarbanes-oxley-act-2002/","nodes":[],"isActive":false},{"title":"Compliance","url":"/en-gb/company/governance/compliance/","nodes":[],"isActive":false}],"isActive":false},{"title":"Policy positions","url":"/en-gb/company/policy-positions/","nodes":[],"isActive":false},{"title":"Codes, standards and reports","url":"/en-gb/company/codes-standards-and-reports/","nodes":[],"isActive":false}],"isActive":false,"promos":[{"text":"Our purpose, strategy and culture","image":{"src":"/media/vvwddvsg/gsk_tech_human_image_6k.jpg?rxy=0.56833333333333336,0.30177514792899407&width=329&height=185&format=webp&quality=100&v=1dba2ec0bc1e680","alt":"GSK Tech Human Image","darkModeSrc":"/media/vvwddvsg/gsk_tech_human_image_6k.jpg?rxy=0.56833333333333336,0.30177514792899407&width=329&height=185&format=webp&quality=50&v=1dba2ec0bc1e680"},"link":{"text":"FEATURED SECTION","href":"/en-gb/company/purpose-strategy-and-culture/","openInNewWindowText":null}},{"text":"Outstanding people","image":{"src":"/media/kgwp0dc5/sddefault-2.jpg?rxy=0.425,0.51807228915662651&width=329&height=185&format=webp&quality=100&v=1dba2eba773f3d0","alt":"Angeles sitting on a sofa in a pink shirt","darkModeSrc":"/media/kgwp0dc5/sddefault-2.jpg?rxy=0.425,0.51807228915662651&width=329&height=185&format=webp&quality=50&v=1dba2eba773f3d0"},"link":{"text":"FEATURED SECTION","href":"/en-gb/company/outstanding-people/","openInNewWindowText":null}}]},{"tooltip":null,"hasBorderRight":false,"title":"Innovation","url":"/en-gb/innovation/","nodes":[{"title":"Our leading scientists","url":"/en-gb/innovation/our-leading-scientists/","nodes":[{"title":"Dr Tony Wood","url":"/en-gb/innovation/our-leading-scientists/tony-wood/","nodes":[],"isActive":false},{"title":"Dr Sabine Luik","url":"/en-gb/innovation/our-leading-scientists/sabine-luik/","nodes":[],"isActive":false},{"title":"Dr Hesham Ahmed Abdullah","url":"/en-gb/innovation/our-leading-scientists/hesham-abdullah/","nodes":[],"isActive":false},{"title":"Dr Kaivan Khavandi","url":"/en-gb/innovation/our-leading-scientists/kaivan-khavandi/","nodes":[],"isActive":false}],"isActive":false},{"title":"Research and development approach","url":"/en-gb/innovation/research-and-development-approach/","nodes":[],"isActive":false},{"title":"Pipeline","url":"/en-gb/innovation/pipeline/","nodes":[],"isActive":false},{"title":"Therapeutic areas","url":"/en-gb/innovation/therapeutic-areas/","nodes":[{"title":"Respiratory, immunology and inflammation","url":"/en-gb/innovation/therapeutic-areas/respiratory-immunology-and-inflammation/","nodes":[],"isActive":false},{"title":"Oncology","url":"/en-gb/innovation/therapeutic-areas/oncology/","nodes":[],"isActive":false},{"title":"HIV","url":"/en-gb/innovation/therapeutic-areas/hiv/","nodes":[],"isActive":false},{"title":"Infectious diseases","url":"/en-gb/innovation/therapeutic-areas/infectious-diseases/","nodes":[],"isActive":false}],"isActive":false},{"title":"Tech","url":"/en-gb/innovation/technologies/","nodes":[],"isActive":false},{"title":"Clinical trials at GSK","url":"/en-gb/innovation/trials/","nodes":[{"title":"Provision of unapproved medicines for unmet medical needs","url":"/en-gb/innovation/trials/provision-of-unlicensed-medicines-for-unmet-medical-needs/","nodes":[],"isActive":false},{"title":"Data transparency","url":"/en-gb/innovation/trials/data-transparency/","nodes":[],"isActive":false},{"title":"Representative clinical studies","url":"/en-gb/innovation/trials/representative-clinical-studies/","nodes":[],"isActive":false}],"isActive":false},{"title":"Partnering with GSK","url":"/en-gb/innovation/partnerships/","nodes":[{"title":"Supported studies","url":"/en-gb/innovation/partnerships/supported-studies/","nodes":[],"isActive":false}],"isActive":false},{"title":"R&D locations","url":"/en-gb/innovation/rd-locations/","nodes":[],"isActive":false}],"isActive":false,"promos":[{"text":"Behind the science magazine","image":{"src":"/media/ukvllwft/vaccine-manufacturing-production-line-2.jpg?width=329&height=185&format=webp&quality=100&v=1dba2ebb585f130","alt":"Scientist works in a futurist vaccine laboratory for GSK","darkModeSrc":"/media/ukvllwft/vaccine-manufacturing-production-line-2.jpg?width=329&height=185&format=webp&quality=50&v=1dba2ebb585f130"},"link":{"text":"SPOTLIGHT ON","href":"/en-gb/behind-the-science-magazine/","openInNewWindowText":null}},{"text":"Our leading scientists","image":{"src":"/media/45khexa4/tony-16x9.jpg?rxy=0.5733215608441357,0.39891812701082546&width=329&height=185&format=webp&quality=100&v=1dc651e856734f0","alt":"Tony Wood","darkModeSrc":"/media/45khexa4/tony-16x9.jpg?rxy=0.5733215608441357,0.39891812701082546&width=329&height=185&format=webp&quality=50&v=1dc651e856734f0"},"link":{"text":"Featured section","href":"/en-gb/innovation/our-leading-scientists/","openInNewWindowText":null}}]},{"tooltip":null,"hasBorderRight":false,"title":"Products","url":"/en-gb/products/","nodes":[{"title":"Product areas","url":"/en-gb/products/our-product-areas/","nodes":[],"isActive":false},{"title":"Products A-Z","url":"/en-gb/products/products-a-z/","nodes":[],"isActive":false}],"isActive":false,"promos":[{"text":"Innovation","image":{"src":"/media/jxkd3fld/web03-header-stvg_2_2022_port_5_hess_nav.jpg?width=329&height=185&format=webp&quality=100&v=1dba2ebbe22d650","alt":"Lab technician leaning against wall","darkModeSrc":"/media/jxkd3fld/web03-header-stvg_2_2022_port_5_hess_nav.jpg?width=329&height=185&format=webp&quality=50&v=1dba2ebbe22d650"},"link":{"text":"SPOTLIGHT ON","href":"/en-gb/innovation/","openInNewWindowText":null}},{"text":"GSKPro for healthcare professionals ","image":{"src":"/media/xpibjmpq/navthumb_stvg_03_2022_port_32_eagle_orange-1.jpg?width=329&height=185&format=webp&quality=100&v=1dba2ebbe35c210","alt":"Two scientists on orange background","darkModeSrc":"/media/xpibjmpq/navthumb_stvg_03_2022_port_32_eagle_orange-1.jpg?width=329&height=185&format=webp&quality=50&v=1dba2ebbe35c210"},"link":{"text":"FEATURED WEBSITE","href":"https://gskpro.com","target":"_blank","openInNewWindowText":"Opens in a new window"}}]},{"tooltip":null,"hasBorderRight":true,"title":"Responsibility","url":"/en-gb/responsibility/","nodes":[{"title":"Access","url":"/en-gb/responsibility/access/","nodes":[],"isActive":false},{"title":"Global health and health security","url":"/en-gb/responsibility/global-health-and-health-security/","nodes":[{"title":"Global health","url":"/en-gb/responsibility/global-health-and-health-security/global-health/","nodes":[],"isActive":false},{"title":"Health security","url":"/en-gb/responsibility/global-health-and-health-security/health-security/","nodes":[],"isActive":false},{"title":"Using our science for global health","url":"/en-gb/responsibility/global-health-and-health-security/using-our-science-for-global-health/","nodes":[],"isActive":false},{"title":"Improving access to healthcare","url":"/en-gb/responsibility/global-health-and-health-security/improving-access-to-healthcare/","nodes":[],"isActive":false},{"title":"Africa Open Lab","url":"/en-gb/responsibility/global-health-and-health-security/africa-open-lab/","nodes":[],"isActive":false}],"isActive":false},{"title":"Environment","url":"/en-gb/responsibility/environment/","nodes":[{"title":"Climate","url":"/en-gb/responsibility/environment/climate/","nodes":[],"isActive":false},{"title":"Freshwater","url":"/en-gb/responsibility/environment/freshwater/","nodes":[],"isActive":false},{"title":"Land","url":"/en-gb/responsibility/environment/land/","nodes":[],"isActive":false},{"title":"Oceans","url":"/en-gb/responsibility/environment/oceans/","nodes":[],"isActive":false},{"title":"Materials and waste","url":"/en-gb/responsibility/environment/materials-and-waste/","nodes":[],"isActive":false},{"title":"Health system sustainability","url":"/en-gb/responsibility/environment/health-system-sustainability/","nodes":[],"isActive":false}],"isActive":false},{"title":"Inclusion","url":"/en-gb/responsibility/inclusion/","nodes":[],"isActive":false},{"title":"Ethical standards","url":"/en-gb/responsibility/ethical-standards/","nodes":[{"title":"Working with third parties","url":"/en-gb/responsibility/ethical-standards/working-with-third-parties/","nodes":[],"isActive":false},{"title":"Public policy and patient advocacy","url":"/en-gb/responsibility/ethical-standards/public-policy-and-patient-advocacy/","nodes":[],"isActive":false},{"title":"Human rights","url":"/en-gb/responsibility/ethical-standards/human-rights/","nodes":[],"isActive":false},{"title":"Use of animals","url":"/en-gb/responsibility/ethical-standards/use-of-animals/","nodes":[],"isActive":false},{"title":"Engaging with healthcare professionals","url":"/en-gb/responsibility/ethical-standards/engaging-with-healthcare-professionals/","nodes":[],"isActive":false}],"isActive":false},{"title":"Product governance","url":"/en-gb/responsibility/product-governance/","nodes":[],"isActive":false},{"title":"Grants and donations","url":"/en-gb/responsibility/grants-and-donations/","nodes":[],"isActive":false},{"title":"Charitable investments ","url":"/en-gb/responsibility/charitable-investments/","nodes":[],"isActive":false},{"title":"Responsibility reports","url":"/en-gb/responsibility/responsibility-reports/","nodes":[{"title":"Reports archive","url":"/en-gb/responsibility/responsibility-reports/responsibility-reports-archive/","nodes":[],"isActive":false}],"isActive":false}],"isActive":false,"promos":[{"text":"Inclusion","image":{"src":"/media/2u2dowa1/web16-header-stvg_2_2022_port_13_hess_nav.jpg?width=329&height=185&format=webp&quality=100&v=1dba2ebc1b88030","alt":"Lab technician smiling","darkModeSrc":"/media/2u2dowa1/web16-header-stvg_2_2022_port_13_hess_nav.jpg?width=329&height=185&format=webp&quality=50&v=1dba2ebc1b88030"},"link":{"text":"FEATURED SECTION","href":"/en-gb/responsibility/inclusion/","openInNewWindowText":null}},{"text":"Our policy positions","image":{"src":"/media/110ltmz5/gsk_texture_fluid_03_a_cmyk_web-size_nav.jpg?width=329&height=185&format=webp&quality=100&v=1dba2ebbe9b61b0","alt":"GSK orange texture","darkModeSrc":"/media/110ltmz5/gsk_texture_fluid_03_a_cmyk_web-size_nav.jpg?width=329&height=185&format=webp&quality=50&v=1dba2ebbe9b61b0"},"link":{"text":"SPOTLIGHT ON","href":"/en-gb/company/policy-positions/","openInNewWindowText":null}}]},{"tooltip":null,"hasBorderRight":false,"title":"Investors","url":"/en-gb/investors/","nodes":[{"title":"Why invest in GSK?","url":"/en-gb/investors/why-invest-in-gsk/","nodes":[],"isActive":false},{"title":"Quarterly results","url":"/en-gb/investors/quarterly-results/","nodes":[],"isActive":false},{"title":"Financial reports","url":"/en-gb/investors/financial-reports/","nodes":[{"title":"Annual Report 2025","url":"/en-gb/investors/financial-reports/annual-report-2025/","nodes":[],"isActive":false},{"title":"Corporate reports archive","url":"/en-gb/investors/financial-reports/corporate-reports-archive/","nodes":[],"isActive":false}],"isActive":false},{"title":"Responsible business","url":"/en-gb/investors/responsible-business/","nodes":[],"isActive":false},{"title":"Speeches and presentations","url":"/en-gb/investors/speeches-and-presentations/","nodes":[],"isActive":false},{"title":"Science publications","url":"/en-gb/investors/science-publications/","nodes":[],"isActive":false},{"title":"Events calendar","url":"/en-gb/investors/events-calendar/","nodes":[],"isActive":false},{"title":"Dividend and share price","url":"/en-gb/investors/dividend-and-share-price/","nodes":[{"title":"GSK share price","url":"/en-gb/investors/dividend-and-share-price/gsk-share-price/","nodes":[],"isActive":false},{"title":"Share price calculators (GBp/USD)","url":"/en-gb/investors/dividend-and-share-price/share-price-calculators-gbpusd/","nodes":[],"isActive":false},{"title":"Dividend calculators (GBp/USD)","url":"/en-gb/investors/dividend-and-share-price/dividend-calculators-gbpusd/","nodes":[],"isActive":false},{"title":"Dividend calendar","url":"/en-gb/investors/dividend-and-share-price/dividend-calendar/","nodes":[],"isActive":false}],"isActive":false},{"title":"Analyst consensus","url":"/en-gb/investors/analyst-consensus/","nodes":[],"isActive":false},{"title":"Stock exchange announcements","url":"/en-gb/investors/stock-exchange-announcements/","nodes":[{"title":"London (RNS)","url":"/en-gb/investors/stock-exchange-announcements/london-rns/","nodes":[],"isActive":false},{"title":"London (RNS) inside information","url":"/en-gb/investors/stock-exchange-announcements/london-rns-inside-information/","nodes":[],"isActive":false},{"title":"New York (SEC)","url":"/en-gb/investors/stock-exchange-announcements/new-york-sec/","nodes":[],"isActive":false},{"title":"Sign up for announcements","url":"/en-gb/investors/stock-exchange-announcements/sign-up-for-announcements/","nodes":[],"isActive":false}],"isActive":false},{"title":"Shareholder information","url":"/en-gb/investors/shareholder-information/","nodes":[{"title":"Manage your shares","url":"/en-gb/investors/shareholder-information/manage-your-shares/","nodes":[],"isActive":false},{"title":"Annual General Meeting","url":"/en-gb/investors/shareholder-information/annual-general-meeting/","nodes":[],"isActive":false},{"title":"General Meeting","url":"/en-gb/investors/shareholder-information/general-meeting/","nodes":[],"isActive":false},{"title":"Annual Governance Meeting","url":"/en-gb/investors/shareholder-information/annual-governance-meeting/","nodes":[],"isActive":false},{"title":"Corporate sponsored nominee service","url":"/en-gb/investors/shareholder-information/corporate-sponsored-nominee-service/","nodes":[],"isActive":false},{"title":"Our ADR programme","url":"/en-gb/investors/shareholder-information/adr-programme/","nodes":[],"isActive":false},{"title":"Asset reunification - Georgeson ","url":"/en-gb/investors/shareholder-information/asset-reunification-georgeson/","nodes":[],"isActive":false},{"title":"Share scam alert","url":"/en-gb/investors/shareholder-information/share-scam-alert/","nodes":[],"isActive":false},{"title":"Privacy notice for ordinary shareholders","url":"/en-gb/investors/shareholder-information/privacy-notice-for-ordinary-shareholders/","nodes":[],"isActive":false},{"title":"FAQs","url":"/en-gb/investors/shareholder-information/shareholder-faqs/","nodes":[],"isActive":false}],"isActive":false},{"title":"Corporate actions","url":"/en-gb/investors/corporate-actions/","nodes":[{"title":"Consumer Healthcare Demerger","url":"/en-gb/investors/corporate-actions/consumer-healthcare-demerger/","nodes":[],"isActive":false},{"title":"Consumer Healthcare Joint Venture","url":"/en-gb/investors/corporate-actions/consumer-healthcare-joint-venture/","nodes":[],"isActive":false},{"title":"Agreement to acquire TESARO","url":"/en-gb/investors/corporate-actions/agreement-to-acquire-tesaro/","nodes":[],"isActive":false}],"isActive":false},{"title":"Debt investors","url":"/en-gb/investors/debt-investors/","nodes":[],"isActive":false},{"title":"Investor contacts","url":"/en-gb/investors/investor-contacts/","nodes":[],"isActive":false}],"isActive":false,"promos":[{"text":"Press releases","image":{"src":"/media/hb1dfygw/ware_3_2022_prodassmb_28_hess_nav.jpeg?width=329&height=185&format=webp&quality=100&v=1dba2ebc6f12bb0","alt":"Lab machinery","darkModeSrc":"/media/hb1dfygw/ware_3_2022_prodassmb_28_hess_nav.jpeg?width=329&height=185&format=webp&quality=50&v=1dba2ebc6f12bb0"},"link":{"text":"SPOTLIGHT ON","href":"/en-gb/media/press-releases/","openInNewWindowText":null}},{"text":"Our pipeline","image":{"src":"/media/2kyan0vw/ware_3_2022_prodqc_14_hess.jpeg?width=329&height=185&format=webp&quality=100&v=1dba2ebc701f490","alt":"Case of vials","darkModeSrc":"/media/2kyan0vw/ware_3_2022_prodqc_14_hess.jpeg?width=329&height=185&format=webp&quality=50&v=1dba2ebc701f490"},"link":{"text":"SPOTLIGHT ON","href":"/en-gb/innovation/pipeline/","openInNewWindowText":null}}]},{"tooltip":null,"hasBorderRight":false,"title":"Media","url":"/en-gb/media/","nodes":[{"title":"Press releases","url":"/en-gb/media/press-releases/","nodes":[],"isActive":true},{"title":"Media contacts","url":"/en-gb/media/media-contacts/","nodes":[],"isActive":false},{"title":"Media library","url":"/en-gb/media/media-library/","nodes":[],"isActive":false},{"title":"Zantac litigation","url":"/en-gb/media/zantac-litigation/","nodes":[],"isActive":false},{"title":"Our social media","url":"/en-gb/media/social-media/","nodes":[],"isActive":false},{"title":"Podcasts","url":"/en-gb/media/podcasts/","nodes":[],"isActive":false},{"title":"RSS feeds","url":"/en-gb/media/rss-feeds/","nodes":[],"isActive":false}],"isActive":true,"promos":[{"text":"Behind the science magazine","image":{"src":"/media/ukvllwft/vaccine-manufacturing-production-line-2.jpg?width=329&height=185&format=webp&quality=100&v=1dba2ebb585f130","alt":"Scientist works in a futurist vaccine laboratory for GSK","darkModeSrc":"/media/ukvllwft/vaccine-manufacturing-production-line-2.jpg?width=329&height=185&format=webp&quality=50&v=1dba2ebb585f130"},"link":{"text":"Spotlight on","href":"/en-gb/behind-the-science-magazine/","openInNewWindowText":null}}]},{"tooltip":null,"hasBorderRight":false,"title":"Careers","url":"/en-gb/careers/","nodes":[{"title":"Search jobs","url":"/en-gb/careers/search-jobs/","nodes":[],"isActive":false},{"title":"Featured careers","url":"/en-gb/careers/featured-careers/","nodes":[{"title":"A career in data","url":"/en-gb/careers/featured-careers/a-career-in-data/","nodes":[],"isActive":false}],"isActive":false},{"title":"Life at GSK","url":"/en-gb/careers/life-at-gsk/","nodes":[],"isActive":false},{"title":"Experienced professionals","url":"/en-gb/careers/experienced-professionals/","nodes":[{"title":"Business operations","url":"/en-gb/careers/experienced-professionals/business-operations/","nodes":[],"isActive":false},{"title":"Engineering at GSK ","url":"/en-gb/careers/experienced-professionals/engineering/","nodes":[],"isActive":false},{"title":"Global supply chain","url":"/en-gb/careers/experienced-professionals/global-supply-chain/","nodes":[],"isActive":false},{"title":"Sales and marketing","url":"/en-gb/careers/experienced-professionals/sales-and-marketing/","nodes":[],"isActive":false},{"title":"Research and development","url":"/en-gb/careers/experienced-professionals/research-and-development/","nodes":[{"title":"Chemical Manufacturing and Controls (CMC), Medicine Development and Supply (MDS)","url":"/en-gb/careers/experienced-professionals/research-and-development/chemical-manufacturing-and-controls-cmc-medicine-development-and-supply-mds/","nodes":[],"isActive":false},{"title":"Genomic sciences","url":"/en-gb/careers/experienced-professionals/research-and-development/genomic-sciences/","nodes":[],"isActive":false}],"isActive":false},{"title":"Technology","url":"/en-gb/careers/experienced-professionals/technology/","nodes":[],"isActive":false}],"isActive":false},{"title":"Early careers","url":"/en-gb/careers/early-careers/","nodes":[{"title":"Application process","url":"/en-gb/careers/early-careers/application-process/","nodes":[],"isActive":false},{"title":"Apprentice programmes","url":"/en-gb/careers/early-careers/apprentice-programmes/","nodes":[],"isActive":false},{"title":"Internships and placements","url":"/en-gb/careers/early-careers/internships-and-placements/","nodes":[],"isActive":false},{"title":"Graduate programme","url":"/en-gb/careers/early-careers/graduate-programme/","nodes":[{"title":"Business operations","url":"/en-gb/careers/early-careers/graduate-programme/business-operations/","nodes":[],"isActive":false},{"title":"Engineering","url":"/en-gb/careers/early-careers/graduate-programme/engineering/","nodes":[],"isActive":false},{"title":"Manufacturing & supply","url":"/en-gb/careers/early-careers/graduate-programme/manufacturing-supply/","nodes":[],"isActive":false},{"title":"Commercial ","url":"/en-gb/careers/early-careers/graduate-programme/commercial/","nodes":[],"isActive":false},{"title":"Research & development","url":"/en-gb/careers/early-careers/graduate-programme/research-development/","nodes":[],"isActive":false},{"title":"Digital & tech","url":"/en-gb/careers/early-careers/graduate-programme/digital-tech/","nodes":[],"isActive":false},{"title":"Manufacturing sciences & technology","url":"/en-gb/careers/early-careers/graduate-programme/manufacturing-sciences-technology/","nodes":[],"isActive":false}],"isActive":false},{"title":"Post graduate opportunities","url":"/en-gb/careers/early-careers/post-graduate-opportunities/","nodes":[],"isActive":false},{"title":"Frequently asked questions","url":"/en-gb/careers/early-careers/frequently-asked-questions/","nodes":[],"isActive":false}],"isActive":false},{"title":"Veterans","url":"/en-gb/careers/veterans/","nodes":[],"isActive":false},{"title":"Our global and regional hubs","url":"/en-gb/careers/our-global-and-regional-hubs/","nodes":[],"isActive":false},{"title":"How we hire","url":"/en-gb/careers/how-we-hire/","nodes":[{"title":"Fraudulent internet recruitment activities","url":"/en-gb/careers/how-we-hire/fraudulent-internet-recruitment-activities/","nodes":[],"isActive":false},{"title":"Frequently asked questions","url":"/en-gb/careers/how-we-hire/frequently-asked-questions/","nodes":[],"isActive":false}],"isActive":false}],"isActive":false,"promos":[{"text":"Outstanding people","image":{"src":"/media/kgwp0dc5/sddefault-2.jpg?rxy=0.425,0.51807228915662651&width=329&height=185&format=webp&quality=100&v=1dba2eba773f3d0","alt":"Angeles sitting on a sofa in a pink shirt","darkModeSrc":"/media/kgwp0dc5/sddefault-2.jpg?rxy=0.425,0.51807228915662651&width=329&height=185&format=webp&quality=50&v=1dba2eba773f3d0"},"link":{"text":"Spotlight on","href":"/en-gb/company/outstanding-people/","openInNewWindowText":null}},{"text":"Inclusion","image":{"src":"/media/2u2dowa1/web16-header-stvg_2_2022_port_13_hess_nav.jpg?width=329&height=185&format=webp&quality=100&v=1dba2ebc1b88030","alt":"Lab technician smiling","darkModeSrc":"/media/2u2dowa1/web16-header-stvg_2_2022_port_13_hess_nav.jpg?width=329&height=185&format=webp&quality=50&v=1dba2ebc1b88030"},"link":{"text":"Spotlight on","href":"/en-gb/responsibility/inclusion/","openInNewWindowText":null}}]}],"skipToContent":"Skip to content","skipToSearch":"Skip to search","typeaheadSearch":{"apiEndpoint":"api/search/typeahead?siteContainerId=1703","searchFieldPlaceholderText":"Enter a search term...","searchPage":"/en-gb/search/","ariaLabel":"Submit form"},"ariaLabel":"Global navigation"},"footer":{"logo":null,"copyrightText":"This is our global website, intended for visitors seeking information on GSK's worldwide business. Our market sites can be reached by visiting our location selector.
\n\n
© 2001-2026 GSK plc. All rights reserved. Trade marks are owned by or licensed to the GSK group of companies.
\nGSK plc. Registered in England and Wales No. 3888792.
\nRegistered office: 79 New Oxford Street, London. United Kingdom. WC1A 1DG
","modernSlaveryStatement":{"name":"Modern Slavery Act Statement 2025","url":"/media/5ladhmeu/modern-slavery-act-statement-2025.pdf","fileExtension":"PDF","fileSize":"187.7KB","type":"file","target":"_blank","openInNewWindowText":"Opens in a new window"},"sections":{"socialMedia":{"columnTitle":"Follow us on:","socialMediaItems":[{"globalLink":{"text":null,"href":"http://www.linkedin.com/company/glaxosmithkline","target":"_blank","openInNewWindowText":"Opens in a new window"},"localLink":null,"ariaLabel":"Visit GSK on Linkedin","customIcon":null,"showPopupMenu":false,"type":"LinkedIn"},{"globalLink":{"text":null,"href":"http://twitter.com/GSK","target":"_blank","openInNewWindowText":"Opens in a new window"},"localLink":null,"ariaLabel":"Visit GSK X page","customIcon":null,"showPopupMenu":false,"type":"X"},{"globalLink":{"text":null,"href":"https://bsky.app/profile/gsk.bsky.social/","target":"_blank","openInNewWindowText":"Opens in a new window"},"localLink":null,"ariaLabel":"","customIcon":null,"showPopupMenu":false,"type":"Bluesky"},{"globalLink":{"text":null,"href":"https://www.instagram.com/gsk/","target":"_blank","openInNewWindowText":"Opens in a new window"},"localLink":null,"ariaLabel":"Visit GSK Instagram","customIcon":null,"showPopupMenu":false,"type":"Instagram"},{"globalLink":{"text":null,"href":"https://www.facebook.com/GSK","target":"_blank","openInNewWindowText":"Opens in a new window"},"localLink":null,"ariaLabel":"Visit GSK Facebook page","customIcon":null,"showPopupMenu":false,"type":"Facebook"},{"globalLink":{"text":null,"href":"http://www.youtube.com/GSK","target":"_blank","openInNewWindowText":"Opens in a new window"},"localLink":null,"ariaLabel":"Visit GSK YouTube Channel","customIcon":null,"showPopupMenu":false,"type":"Youtube"},{"globalLink":{"text":null,"href":"/en-gb/media/rss-feeds/","openInNewWindowText":null},"localLink":null,"ariaLabel":"Visit GSK RSS feeds","customIcon":null,"showPopupMenu":false,"type":"Rss"}]},"columns":[{"columnTitle":"GSK websites","links":[{"text":"Locations selector","href":"/en-gb/locations/","openInNewWindowText":null},{"text":"Social media directory","href":"/en-gb/media/social-media/","openInNewWindowText":null},{"text":"GSKPro for healthcare professionals","href":"https://www.gskpro.com","target":"_blank","openInNewWindowText":"Opens in a new window"},{"text":"GSK study register","href":"https://www.gsk-studyregister.com/en/","target":"_blank","openInNewWindowText":"Opens in a new window"},{"text":"Supplier website","href":"https://supplier.gsk.com","target":"_blank","openInNewWindowText":"Opens in a new window"},{"text":"ViiV Healthcare","href":"https://viivhealthcare.com/","target":"_blank","openInNewWindowText":"Opens in a new window"}]},{"columnTitle":"Quick links","links":[{"text":"Behind the Science magazine","href":"/en-gb/behind-the-science-magazine/","openInNewWindowText":null},{"text":"Company","href":"/en-gb/company/","openInNewWindowText":null},{"text":"Innovation","href":"/en-gb/innovation/","openInNewWindowText":null},{"text":"Products","href":"/en-gb/products/","openInNewWindowText":null},{"text":"Responsibility","href":"/en-gb/responsibility/","openInNewWindowText":null},{"text":"Investors","href":"/en-gb/investors/","openInNewWindowText":null},{"text":"Media","href":"/en-gb/media/","openInNewWindowText":null},{"text":"Careers","href":"/en-gb/careers/","openInNewWindowText":null}]},{"columnTitle":"Get in touch","links":[{"text":"Contact us","href":"/en-gb/contact-us/","openInNewWindowText":null},{"text":"Partnerships","href":"/en-gb/innovation/partnerships/","openInNewWindowText":null},{"text":"Report a possible side effect","href":"/en-gb/contact-us/report-a-possible-side-effect/","openInNewWindowText":null},{"text":"GSK Speak up","href":"https://www.gsk.com/speakup","target":"_blank","openInNewWindowText":"Opens in a new window"}]}]},"bottomLinks":[{"text":"Accessibility","href":"/en-gb/accessibility/","openInNewWindowText":null},{"text":"Digital sustainability","href":"/en-gb/digital-sustainability/","openInNewWindowText":null},{"text":"Terms of use","href":"/en-gb/terms-of-use/","openInNewWindowText":null},{"text":"Cookie policy","href":"/en-gb/cookie-policy/","openInNewWindowText":null},{"text":"Privacy notice","href":"https://privacy.gsk.com/en-gb/privacy-notice/general","target":"_blank","openInNewWindowText":"Opens in a new window"},{"text":"Sitemap","href":"/en-gb/sitemap/","openInNewWindowText":null}],"continueToLink":null,"legalApprovalText":""},"sharing":{"description":"GSK announced, EMA's CHMP is recommending Nucala as an add-on treatment for severe refractory eosinophilic asthma in paediatric patients.","og":[{"property":"og:title","content":"CHMP recommend Nucala (mepolizumab) for the treatment of severe eosinophilic asthma paediatric patients in Europe"},{"property":"og:description","content":"GSK announced, EMA's CHMP is recommending Nucala as an add-on treatment for severe refractory eosinophilic asthma in paediatric patients."},{"property":"og:image","content":"https://www.gsk.com/media/p3clrlre/stvg_2_2022_smtlab_17_hess.jpg?width=600&format=webp&quality=100&v=1dbd496701ca530"},{"property":"og:url","content":"https://www.gsk.com/en-gb/media/press-releases/chmp-recommend-nucala-mepolizumab-for-the-treatment-of-severe-eosinophilic-asthma-paediatric-patients-in-europe/"}],"twitter":[{"name":"twitter:card","content":"summary_large_image"},{"name":"twitter:site","content":"@gsk"},{"name":"twitter:title","content":"CHMP recommend Nucala (mepolizumab) for the treatment of severe eosinophilic asthma paediatric patients in Europe"},{"name":"twitter:description","content":"GSK announced, EMA's CHMP is recommending Nucala as an add-on treatment for severe refractory eosinophilic asthma in paediatric patients."},{"name":"twitter:image","content":"https://www.gsk.com/media/p3clrlre/stvg_2_2022_smtlab_17_hess.jpg?width=600&format=webp&quality=100&v=1dbd496701ca530"},{"name":"twitter:url","content":"https://www.gsk.com/en-gb/media/press-releases/chmp-recommend-nucala-mepolizumab-for-the-treatment-of-severe-eosinophilic-asthma-paediatric-patients-in-europe"}]},"stickyShare":null,"exitSitePreferences":{"popupEnabled":false,"title":"","texts":"","continueText":"Continue","cancelText":"Cancel","exclusionUrls":[]},"settings":{"optionalStylesheetLink":null,"themeColorHexCode":null,"headerLogoLightTheme":null,"headerLogoDarkTheme":null,"footerLogo":{"src":"https://www.gsk.com/media/0jwou3xu/gsk-logo.png?width=104&format=webp&quality=100&v=1dbf4b05a4e6470","alt":"Gsk Logo","darkModeSrc":"https://www.gsk.com/media/0jwou3xu/gsk-logo.png?width=104&format=webp&quality=50&v=1dbf4b05a4e6470"},"scripts":[{"pageLocation":"Top","text":" \n"}],"globalWebsiteLink":null,"googleMapsApiKey":"AIzaSyA2QMg4Ww6djPKb7b9BraQn4kgJmDaLblg","textToSpeechApiKey":"70ab0a79-1d92-4286-86d2-abdd71cc785c","bingVerificationCode":"","googleAnalytics":"","siteTitle":" | GSK"},"pageSettings":{"disableBackToTopButton":false,"backToTopButtonText":"Back to top","robotsNoFollow":false,"robotsNoIndex":false,"canonicalUrl":"https://www.gsk.com/en-gb/media/press-releases/chmp-recommend-nucala-mepolizumab-for-the-treatment-of-severe-eosinophilic-asthma-paediatric-patients-in-europe/"},"tealiumSettings":{"enabled":false,"data":""},"entryPopup":{"title":"","text":"You are about to access GSK historic archived press release material retained as a corporate record. References to products or their uses may be out of date and not reflect current medical, safety or regulatory information. For clinical information, consult the approved national product label information (SmPC).
","continueText":"Continue","cancelText":"Cancel"},"protectedPage":false,"schema":{"jsonLdSchemas":["{\"@context\":\"https://schema.org\",\"@type\":\"NewsArticle\",\"description\":\"GSK announced, EMA\\u0027s CHMP is recommending Nucala as an add-on treatment for severe refractory eosinophilic asthma in paediatric patients.\",\"mainEntityOfPage\":\"https://www.gsk.com/en-gb/media/press-releases/chmp-recommend-nucala-mepolizumab-for-the-treatment-of-severe-eosinophilic-asthma-paediatric-patients-in-europe/\",\"author\":{\"@type\":\"Organization\",\"name\":\"GSK\",\"url\":\"https://www.gsk.com/en-gb/\"},\"datePublished\":\"2018-07-27T14:56:53+00:00\",\"headline\":\"CHMP recommend Nucala (mepolizumab) for the treatment of severe eosinophilic asthma paediatric patients in Europe\",\"keywords\":\"Medicines,Research and development\",\"articleSection\":\"Press releases\"}"]}}