FDA Approvals of NMEs and BLAs Increased in 2012

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Additional approvals in December have helped to outpace a recent high set in 2011.

The year 2012 proved to be a good one for FDA approval of new molecular entities (NMEs) and new biologic license applications (BLAs) by FDA’s Center for Drug Evaluation and Research. For the month of December 2012 (as of Dec. 31, 2012), FDA approved seven new drugs to bring the total of NMEs and BLAs approved by FDA’s CDER through Dec. 31, 2012, at 39, outpacing the 30 NME and BLAs that FDA’s CDER approved in 2011.

December is typically an active month for FDA approvals, and December 2012 was no exception. For December 2012 (as of Dec. 31, 2012), FDA’s CDER approved seven new drugs. Ariad Pharmaceuticals received approval for Iclusig (ponatinib) for treating adult patients with chronic, accelerated or blast phase chronic myeloid leukemia that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia that is resistant or intolerant to prior TKI therapy. Novartis received FDA approval for Signifor (pasireotide diaspartate) for treating adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative. NPS Pharmaceuticals received FDA approval for Gattex (teduglutide [rDNA origin]) for injection for subcutaneous use for treating adult patients with short bowel syndrome who are dependent on parenteral support. Aegerion Pharmaceuticals received approval for Juxtapid (lomitapide) capsules as an adjunct to a low-fat diet and other lipid-lowering treatments to reduce low-density lipoprotein cholesterol, total cholesterol, apolipoprotein B, and non-high-density-lipoprotein cholesterol in patients with homozygous familial hypercholesterolemia.

At year-end, FDA approved three additional new drugs. Bristol-Myers Squibb received FDA approval for Eliquis (apixaban), an oral Factor Xa inhibitor anticoagulant to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation that is not caused by a heart-valve problem. In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize Eliquis, which was discovered by Bristol-Myers Squibb. Johnson & Johnson’s Janssen Therapeutics received FDA approval for Sirturo (bedaquiline) as part of a combination therapy to treat multidrug-resistant tuberculosis. FDA also approved Salix Pharmaceuticals’ Fulyzaq (crofelemer), a drug to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy.

Also, GlaxoSmithKline (GSK) received FDA approval for its BLA for raxibacumab, a monoclonal antibody to treat inhalational anthrax (see related story, “FDA Approves First Anthrax Antitoxin”). Raxibacumab was developed by Human Genome Sciences (HGS) in conjunction with the Biomedical Advanced Research and Development Authority of the Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services. HGS was acquired by GSK in July 2012, making raxibacumab part of GSK’s portfolio. HGS received approval for raxibacumab as a new manufacturer based on its BLA submission earlier in 2012.


In addition to the new drug approvals in December 2012,  FDA’s CDER approved  on Nov. 29, 2012, Exelixis’ Cometriq (cabozantinib), a kinase inhibitor to treat progressive, metastatic medullary thyroid cancer. Through Nov. 20, 2012, FDA’s CDER had approved 31 NMEs and BLAs (see related story, “The Class of 2012 for New Molecular Entities and Biologics”). The addition of the approval of Cometriq and the additional new drug approvals (excluding raxibacumab) for December 2012 (as of Dec, 31, 2012) brought the number of NME and BLA approvals by FDA’s CDER to 39 for 2012 (as of Dec. 31, 2012).

Editor's Note: This story was updated on Jan. 2, 2013, to reflect additional year-end approvals.