Michele Phelps Phil 2009-03-03T12:15:45Z 2001-07-25T16:54:03Z 2009-03-03T15:14:13Z Glaxo Wellcome 11.0 16 #9999FF 17 #993366 18 #FFFFCC 19 #CCFFFF 20 #660066 21 #FF8080 22 #0066CC 23 #CCCCFF 24 #000080 25 #FF00FF 26 #FFFF00 27 #00FFFF 28 #800080 29 #800000 30 #008080 31 #0000FF 18040 24500 40 100 566 1 1 False False QueryRef Domain Universe QueryName Header RowStrategy ColumnStrategy CreationDate RefreshDate RefreshOrder Created By Refreshed By Action AutoFit AutoFormat Description User Strategy Security Domain SheetHidden 0 3 1 R2 False False Biopharmaceuticals 249320.0 monoclonal antibody stroke NCE I Biopharmaceuticals 933776.0 monoclonal antibody Alzheimer's disease NCE I Biopharmaceuticals iboctadekin** + Doxil IL18 immunomodulator + topoisomerase II inhibitor ovarian cancer PLE I Biopharmaceuticals iboctadekin** + rituximab IL18 immunomodulator + anti-CD20 monoclonal antibody non-Hodgkin's lymphoma NCE I Biopharmaceuticals 315234.0 monoclonal antibody rheumatoid arthritis NCE II Biopharmaceuticals 679586.0 monoclonal antibody severe asthma NCE II Biopharmaceuticals belimumab** anti-B lymphocyte stimulator monoclonal antibody (s.c.) systemic lupus erythematosus PLE II Biopharmaceuticals mepolizumab anti-IL5 monoclonal antibody severe asthma & nasal polyposis NCE II Biopharmaceuticals ofatumumab** anti-CD20 human monoclonal antibody diffuse large B cell lymphoma PLE II Biopharmaceuticals ofatumumab** anti-CD20 human monoclonal antibody multiple sclerosis NCE II Biopharmaceuticals belimumab** anti-B lymphocyte stimulator monoclonal antibody (i.v.) systemic lupus erythematosus NCE III Biopharmaceuticals ofatumumab** anti-CD20 human monoclonal antibody follicular lymphoma PLE III Biopharmaceuticals ofatumumab** anti-CD20 human monoclonal antibody rheumatoid arthritis NCE III Biopharmaceuticals otelixizumab** anti-CD3 monoclonal antibody type 1 diabetes NCE III Biopharmaceuticals Syncria** glucagon-like peptide 1 agonist type 2 diabetes NCE III Biopharmaceuticals Bosatria (mepolizumab) anti-IL5 monoclonal antibody hypereosinophilic syndrome NCE Submitted S:Sep08 Biopharmaceuticals ofatumumab** anti-CD20 human monoclonal antibody refractory chronic lymphocytic leukaemia NCE Submitted S:Feb09 S:Jan09 Cardiovascular & Metabolic 256073.0 high affinity nicotinic acid receptor (HM74A) agonist dyslipidaemia NCE I Cardiovascular & Metabolic 1.278863E6 prolyl hydroxylase inhibitor anaemia NCE I Cardiovascular & Metabolic 1.292263E6 gastrin-releasing peptide (GRP) receptor agonist type 2 diabetes NCE I Cardiovascular & Metabolic 1.521498E6 mu-opioid receptor inverse agonist obesity NCE I Cardiovascular & Metabolic 1614235** sodium dependent glucose transport (SGLT1) inhibitor type 2 diabetes NCE I Cardiovascular & Metabolic 2.24584E6 SIRT1 activator type 2 diabetes (also chronic obstructive pulmonary disease, COPD) NCE I Cardiovascular & Metabolic 221149.0 oxytocin antagonist threatened pre-term labour NCE II Cardiovascular & Metabolic 756050.0 bile acid receptor agonist type 2 diabetes NCE II Cardiovascular & Metabolic 184072.0 SIRT1 activator type 2 diabetes (also oncology indications) NCE II Cardiovascular & Metabolic losmapimod (856553) p38 kinase inhibitor cardiovascular disease (also COPD & depression) NCE II Cardiovascular & Metabolic pazopanib multi-kinase angiogenesis inhibitor (eye drops) age-related macular degeneration (also cancer indications) NCE II Cardiovascular & Metabolic remogliflozin etabonate** SGLT2 inhibitor type 1 diabetes PLE II Cardiovascular & Metabolic remogliflozin etabonate** SGLT2 inhibitor type 2 diabetes NCE II Cardiovascular & Metabolic rilapladib** Lp-PLA2 inhibitor atherosclerosis NCE II Cardiovascular & Metabolic ronacaleret** calcium antagonist osteoporosis & fracture healing NCE II Cardiovascular & Metabolic Avandamet XR PPAR gamma agonist + metformin type 2 diabetes - extended release PLE III N/A Cardiovascular & Metabolic Avandia + simvastatin PPAR gamma agonist + statin type 2 diabetes PLE III N/A Cardiovascular & Metabolic darapladib** Lp-PLA2 inhibitor atherosclerosis NCE III Cardiovascular & Metabolic Arixtra synthetic factor Xa inhibitor treatment of acute coronary syndrome PLE Approved A: Aug07 AL:Feb07 & Sep07 Cardiovascular & Metabolic Avandia PPAR gamma agonist prevention of disease progression PLE Approved S:Nov08 A:Jul08 Cardiovascular & Metabolic Volibris** endothelin A antagonist pulmonary arterial hypertension NCE Approved A:Apr08 N/A Infectious Diseases 932121.0 plasmodium electron transport chain inhibitor malaria NCE I Infectious Diseases 945237.0 topoisomerase II inhibitor treatment of bacterial infections NCE I Infectious Diseases 1265744** HIV integrase inhibitor HIV infections NCE I Infectious Diseases 1.322322E6 novel class antibacterial agent treatment of bacterial infections NCE I Infectious Diseases 1349572** HIV integrase inhibitor HIV infections NCE II Infectious Diseases IDX899** non-nucleotide reverse transcriptase inhibitor HIV infections NCE II Infectious Diseases sitamaquine 8-aminoquinoline treatment of visceral leishmaniasis NCE II N/A Infectious Diseases tafenoquine** 8-aminoquinoline Plasmodium vivax malaria NCE II Neurosciences 163090.0 5HT1 antagonist depression & anxiety NCE I Neurosciences 424887.0 NK1 antagonist/SSRI depression & anxiety NCE I Neurosciences 586529** CRF1 antagonist depression & anxiety NCE I Neurosciences 598809.0 dopamine D3 antagonist drug dependency NCE I Neurosciences 618334.0 dopamine D3 antagonist drug dependency NCE I Neurosciences 729327.0 AMPA receptor modulator schizophrenia NCE I Neurosciences 1.014802E6 sodium channel blocker bipolar disorder NCE I Neurosciences 1.018921E6 type 1 glycine transport inhibitor schizophrenia NCE I Neurosciences 1.034702E6 muscarinic acetylcholine agonist dementia NCE I Neurosciences 1.144814E6 NK1/NK3 antagonist schizophrenia NCE I Neurosciences 1.48216E6 purinergic ATP receptor antagonist pain NCE I Neurosciences orvepitant NK1 antagonist depression & anxiety NCE I Neurosciences 239512.0 histamine H3 antagonist dementia NCE II Neurosciences 468816.0 glycine antagonist smoking cessation NCE II Neurosciences 561679** CRF1 antagonist depression & anxiety NCE II Neurosciences 649868** orexin antagonist sleep disorders NCE II Neurosciences 681323.0 p38 kinase inhibitor neuropathic pain NCE II Neurosciences 742457.0 5HT6 antagonist dementia NCE II Neurosciences firategrast** dual alpha4 integrin antagonist (VLA4) multiple sclerosis NCE II Neurosciences losmapimod (856553) p38 kinase inhibitor depression (also cardiovascular disease & COPD) NCE II Neurosciences Solzira (1838262)** voltage-gated calcium channel modulator migraine prophylaxis PLE II Neurosciences Solzira (1838262)** voltage-gated calcium channel modulator neuropathic pain PLE II Neurosciences almorexant** orexin antagonist insomnia NCE III Neurosciences Lamictal XR sodium channel inhibitor epilepsy - partial generalised tonic-clonic seizures, once-daily PLE III N/A 2009.0 Neurosciences retigabine** neuronal potassium channel opener epilepsy - partial seizures NCE III Neurosciences rosiglitazone XR PPAR gamma agonist Alzheimer's disease PLE III Neurosciences Lunivia** non-benzodiazepine GABA agonist insomnia NCE Submitted PO:Oct08 N/A Neurosciences Solzira (1838262)** voltage-gated calcium channel modulator restless legs syndrome NCE Submitted S:Sep08 & Jan09 Neurosciences Lamictal XR sodium channel inhibitor epilepsy - partial seizures, once-daily PLE Approvable N/A AL: Sep07 Neurosciences Requip Modutab/XL** non-ergot dopamine agonist Parkinson’s disease - once-daily controlled release formulation PLE Approved A:Mar07 A:Jun08 Neurosciences Treximet** 5HT1 agonist + naproxen migraine - fixed dose combination PLE Approved N/A A:Apr08 Oncology 461364.0 polo-like kinase inhibitor cancer NCE I Oncology 923295** centromere-associated protein E (CENP-E) inhibitor cancer NCE I Oncology 1120212** mitogen-activated protein kinase inhibitor (MEK1/2) cancer NCE I Oncology totrombopag** thrombopoietin receptor agonist thrombocytopaenia NCE I Oncology 184072.0 SIRT1 activator colon & haematologic cancers (also type 2 diabetes) NCE II Oncology 1363089** mesenchymal-epithelial transition factor (C-met) kinase inhibitor papillary renal cell carcinoma, gastric cancer and head & neck squamous cell carcinoma NCE II Oncology pazopanib multi-kinase angiogenesis inhibitor non-small cell lung cancer PLE II Oncology pazopanib multi-kinase angiogenesis inhibitor ovarian cancer PLE II Oncology pazopanib + Tyverb/Tykerb multi-kinase angiogenesis inhibitor + Her2 and epidermal growth factor receptor (EGFR) dual kinase inhibitor metastatic breast cancer PLE II Oncology Revolade/Promacta** thrombopoietin receptor agonist oncology-related thrombocytopaenia PLE II Oncology Tyverb/Tykerb Her2 and EGFR dual kinase inhibitor head & neck squamous cell carcinoma (unresectable disease) PLE II Oncology Tyverb/Tykerb Her2 and EGFR dual kinase inhibitor refractory inflammatory breast cancer PLE II Oncology Avodart 5-alpha reductase inhibitor reduction in the risk of prostate cancer PLE III 2009.0 2009.0 Oncology elesclomol** oxidative stress inducer metastatic melanoma NCE III 2009.0 Oncology pazopanib multi-kinase angiogenesis inhibitor sarcoma PLE III Oncology pazopanib + Tyverb/Tykerb multi-kinase angiogenesis inhibitor + Her2 and EGFR dual kinase inhibitor inflammatory breast cancer PLE III Oncology Revolade/Promacta** thrombopoietin receptor agonist chronic liver disease induced thrombocytopaenia PLE III Oncology Revolade/Promacta** thrombopoietin receptor agonist hepatitis C induced thrombocytopaenia PLE III Oncology Tyverb/Tykerb Her2 and EGFR dual kinase inhibitor breast cancer, adjuvant therapy PLE III Oncology Tyverb/Tykerb Her2 and EGFR dual kinase inhibitor breast cancer, first line therapy PLE III 2009.0 2009.0 Oncology Tyverb/Tykerb Her2 and EGFR dual kinase inhibitor gastric cancer PLE III Oncology Tyverb/Tykerb Her2 and EGFR dual kinase inhibitor head & neck squamous cell carcinoma (resectable disease) PLE III Oncology Duodart (Avodart + alpha blocker) 5-alpha reductase inhibitor + alpha blocker benign prostatic hyperplasia - fixed dose combination PLE Submitted S:Dec08 2009.0 Oncology pazopanib multi-kinase angiogenesis inhibitor renal cell cancer (also age-related macular degeneration) NCE Submitted S:Feb09 S:Dec08 Oncology Zunrisa/Rezonic NK1 antagonist chemotherapy-induced & postoperative nausea & vomiting NCE Submitted S:Jul08 S:May08 Oncology Hycamtin topoisomerase I inhibitor (oral) small cell lung cancer, second-line therapy PLE Approved A:Mar08 A:Oct07 Oncology Revolade/Promacta** thrombopoietin receptor agonist idiopathic thrombocytopaenic purpura NCE Approved S:Dec08 A:Nov08 Oncology Tyverb/Tykerb Her2 and EGFR dual kinase inhibitor refractory breast cancer NCE Approved A:Jun08 A:Mar07 Respiratory & Immuno-inflammation 610677.0 p38 kinase inhibitor (inhaled) COPD NCE I Respiratory & Immuno-inflammation 656933.0 Chemokine receptor (CXCR2) antagonist cystic fibrosis & COPD NCE I Respiratory & Immuno-inflammation 705498.0 transient receptor potential vanilloid (TRPV1) antagonist (intranasal) non-allergic rhinitis NCE I Respiratory & Immuno-inflammation 962040.0 motilin receptor agonist delayed gastric emptying NCE I Respiratory & Immuno-inflammation 1.399686E6 anti-inflammatory macrolide conjugate (oral) inflammatory bowel disease NCE I Respiratory & Immuno-inflammation 2.24584E6 SIRT1 activator COPD (also type 2 diabetes) NCE I Respiratory & Immuno-inflammation 159797** long-acting beta2 agonist COPD, also COPD & asthma in combination with a glucocorticoid agonist NCE II Respiratory & Immuno-inflammation 159802** long-acting beta2 agonist COPD, also COPD & asthma in combination with a glucocorticoid agonist NCE II Respiratory & Immuno-inflammation 256066.0 PDE IV inhibitor (inhaled) asthma & COPD NCE II Respiratory & Immuno-inflammation 573719.0 muscarinic acetylcholine antagonist COPD NCE II Respiratory & Immuno-inflammation 685698.0 glucocorticoid agonist asthma, also COPD & asthma in combination with a long-acting beta2 agonist NCE II Respiratory & Immuno-inflammation 835726.0 histamine H1/H3 dual antagonist (oral) allergic rhinitis NCE II Respiratory & Immuno-inflammation 870086.0 novel glucocorticoid agonist (inhaled) asthma NCE II Respiratory & Immuno-inflammation 642444** long-acting beta2 agonist COPD, also COPD & asthma in combination with a glucocorticoid agonist NCE II Respiratory & Immuno-inflammation 961081** muscarinic antagonist, beta2 agonist COPD NCE II Respiratory & Immuno-inflammation 1.004723E6 histamine H1/H3 dual antagonist (intranasal) allergic rhinitis NCE II Respiratory & Immuno-inflammation 2190915** 5-lipoxygenase-activating protein (FLAP) inhibitor asthma NCE II Respiratory & Immuno-inflammation darotropium muscarinic acetylcholine antagonist COPD NCE II Respiratory & Immuno-inflammation darotropium + 642444** muscarinic acetylcholine antagonist + long-acting beta2 agonist COPD PLE II Respiratory & Immuno-inflammation losmapimod (856553) p38 kinase inhibitor (oral) COPD (also cardiovascular disease & depression) NCE II Respiratory & Immuno-inflammation Entereg** peripheral mu-opioid antagonist post operative ileus NCE Approved N/A A:May08 Paediatric Vaccines Mosquirix recombinant malaria prophylaxis NBE II Paediatric Vaccines Hib-MenCY-TT conjugated Neisseria meningitis groups C & Y disease & Haemophilus influenzae type b disease prophylaxis NBE III 2009.0 Paediatric Vaccines MenACWY-TT conjugated Neisseria meningitis groups A, C, W & Y disease prophylaxis NBE III Paediatric Vaccines Synflorix conjugated Streptococcus pneumoniae disease prophylaxis in infants & children NBE Submitted PO:Jan09 Paediatric Vaccines Kinrix subunit - inactivated diphtheria, tetanus, pertussis and poliomyelitis prophylaxis (booster - 5th dose) NBE Approved A:Jun08 Paediatric Vaccines Rotarix** live attenuated (oral) rotavirus-induced gastroenteritis prophylaxis NBE Approved A:Feb06 A:Apr08 Other Vaccines Cytomegalovirus recombinant cytomegalovirus infection prophylaxis NBE I Other Vaccines HIV recombinant HIV infection prophylaxis NBE I Other Vaccines NTHi-Pneumo recombinant Streptococcus pneumoniae and Haemophilus influenzae disease prophylaxis in adults NBE I Other Vaccines S. pneumoniae adult recombinant - conjugated Streptococcus pneumoniae disease prophylaxis NBE I Other Vaccines Dengue fever attenuated tetravalent Dengue fever prophylaxis NBE II Other Vaccines Tuberculosis recombinant tuberculosis prophylaxis NBE II Other Vaccines Zoster recombinant Herpes Zoster prevention NBE II Other Vaccines Flu pandemic & pre-pandemic** H5N1 inactivated split - monovalent (Quebec) pandemic influenza prophylaxis NBE III 2009.0 2009.0 Other Vaccines New generation flu vaccine inactivated split - trivalent seasonal influenza prophylaxis for the elderly NBE III Other Vaccines Simplirix recombinant genital herpes prophylaxis NBE III Other Vaccines Boostrix subunit adult booster for diphtheria, tetanus & pertussis BLE Approved A:Jun00 A:Dec08 Other Vaccines Pandemrix (Flu pandemic)** H5N1 inactivated split - monovalent (Dresden) pandemic influenza prophylaxis NBE Approved A:May08 Other Vaccines Prepandrix (Flu pre-pandemic)** H5N1 inactivated split - monovalent (Dresden) pre-pandemic influenza prophylaxis NBE Approved A:May08 Other Vaccines Cervarix** recombinant human papilloma virus infection prophylaxis NBE Approved A:Sep07 AL:Dec07 Antigen Specific Cancer Immunotherapeutic (ASCI) WT1 recombinant treatment of acute myelogenous leukaemia NBE I Antigen Specific Cancer Immunotherapeutic (ASCI) MAGE-A3 ASCI recombinant treatment of melanoma BLE III Antigen Specific Cancer Immunotherapeutic (ASCI) MAGE-A3 ASCI recombinant treatment of non-small cell lung cancer NBE III S: Month of first submission A: Month of NDA or first EU Regulatory approval (for MAA, this is the first EU approval letter) AL: FDA 'Approvable' letter PO: EU Positive Opinion **: In-license or other alliance relationship with a third party