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Synflorix™ receives positive opinion from the CHMP in Europe for additional pneumonia indication

GSK today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an additional indication for Synflorix™, a paediatric pneumococcal conjugate vaccine.

Issued: London UK

GlaxoSmithKline plc (GSK) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an additional indication for Synflorix™, a paediatric pneumococcal conjugate vaccine, for immunisation against pneumonia caused by Streptococcus pneumoniae in infants and children from six weeks up to five years of age.[i]

The application was submitted as a variation to the Marketing Authorisation Application to the European Medicines Agency.

“Pneumonia continues to be one of the leading global killers of children under five years of age, with an estimated three million cases of pneumonia in Europe alone”, said Thomas Breuer, Senior Vice President and Lead Physician of GSK Vaccines. “Vaccination is recognised by The World Health Organization to be the only public health measure likely to have any significant impact on the incidence of pneumococcal pneumonia. Today’s CHMP positive opinion takes us a step closer to offering greater protection to children against this disease. We look forward to the final decision of the European Commission and hope to make Synflorix™ available to more children in Europe.”

A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, but does not always result in marketing authorisation. A final decision by the European Commission is anticipated during the fourth quarter of 2013.

Notes to Editors:

About Synflorix
Synflorix™ is currently approved in the EU and 90 other countries for active immunisation against invasive disease and acute otitis media caused by Streptococcus pneumoniae in infants and children from six weeks up to five years of age. Around 40 countries and regions have chosen Synflorix™ in their universal mass vaccination programmes and 67 countries already have the indication for pneumonia approved. Synflorix™ is not approved for use in the U.S.

Important Safety Information

The most common adverse reactions observed after primary vaccination with Synflorix™ in infants were redness at the injection site and irritability. For further important safety information about the currently licensed indications for Synflorix™, please visit the Electronic Medicines Compendium to view the Synflorix™ EU Patient Information Leaflet.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.

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Cautionary 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. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.

 

[i]   http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/10/news_detail_001927.jsp&mid=WC0b01ac058004d5c1