Fresh From The Pipeline

Original New Drug Approvals (FDA & EMA) in Q3, 2014
NCE/NBE Indication Pharmacological Activity Innovator Regulatory Authority
October 2014
Olaparib - Lynparza™  Ovarian cancer Poly ADP ribose polymerase (PARP) inhibitor AstraZeneca EMA
Nonacog gamma - Rixubis™ Haemophilia B (congenital factor IX deficiency) Blood coagulation factor IX Baxter EMA
Afamelanotide -  Scenesse™ Prevention of phototoxicity in erythropoietic protoporphyria (EPP) Analogue of Alpha-Melanocyte Stimulating Hormone (α-MSH) Clinuvel EMA
Tasimelteon - Hetlioz

Treatment of Non-24-hour disorder in the totally blind

Melatonin receptor agonist Vanda FDA
Netupitant + Palonosetron - Akynzeo™ Prevention of nausea and vomiting during chemotherapy Selective NK₁ receptor antagonist + serotonin subtype 3 (5-HT3) receptor antagonist Helsinn FDA
Ledipasvir + sofosbuvir - Harvoni™ Hepatitis C Infection NS5A replication complex inhibitor + NS5B protease inhibitor Gilead FDA
Pirfenidone - Esbriet™ Idiopathic pulmonary fibrosis (IPF) Unknown InterMune FDA
Nintedanib - Ovef™ Non-small cell lung cancer (NSCLC) Tumour angiogenesis inhibitor Boehringer Ingelheim FDA
September 2014
Pembrolizumab - Keytruda™ Unresectable or metastatic melanoma Anti-PD-1 monoclonal antibody Merck FDA
Naloxegol - Movantik™ Opioid-induced constipation (OIC) Opioid receptor antagonist AstraZeneca FDA
Apremilast -  Otezla™ Psoriatic arthritis Oral, selective inhibitor of phosphodiesterase 4 (PDE4) Celgene FDA
Ledipasvir + sofosbuvir - Harvoni™ Hepatitis C Infection NS5A replication complex inhibitor + NS5B protease inhibitor Gilead EMA
Daclatasvir -Daklinza™ Chronic hepatitis C virus (HCV) infection NS5A replication complex inhibitor Bristol-Myers Squibb EMA
Ramucirumab - Cyramza™ Advanced gastric cancer or gastro-oesophageal junction adenocarcinoma Anti-VEGFR monoclonal antibody Eli Lily EMA
Balugrastim - Egranli™ Prophylaxis against chemotherapy-induced neutropenia Granulocyte colony-stimulating factor Teva EMA
Dulaglutide -Trulicity™ Type 2 Diabetes Mellitus Glucagon-like peptide 1 (GLP-1) receptor agonist Eli Lily EMA
Nintedanib - Vargatef™ Non-small cell lung cancer (NSCLC) Tumour angiogenesis inhibitor Boehringer Ingelheim EMA
Darunavir + cobicistat - Rezolsta™ HIV-1 infection HIV-1 protease inhibitor + CYP3A inhibitor Janssen EMA
August 2014
Ibrutinib - Imbruvica™ Chronic lymphocytic leukemia (CLL) Small-molecule inhibitor of Bruton's tyrosine kinase (BTK) Janssen EMA
Idelalisib - Zydelig™ Chronic Lymphocytic Leukemia (CLL) Small molecule inhibitor of phosphoinositide-3 kinase (PI3K) Gilead EMA
Empagliflozin - Jardiance™ Type 2 Diabetes Mellitus Sodium-glucose co-transporter 2 (SGLT2) inhibitor Boehringer Ingelheim FDA
Oritavancin - Orbactiv™ Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Antibiotic for Gram-positive infections The Medicines Company FDA
Suvorexant - Belsomra™ Insomnia Selective antagonist of orexin receptors Merck FDA
Eliglustat - Cerdelga™ Gaucher Disease type 1 Selective inhibitor of glucosylceramide synthase Genzyme FDA
New Drug Approval References:
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