2012: Winners & Losers of the Pharmaceutical Industry - Drug Approvals and Failures of 2012

In 2012, the FDA approved 33 New Molecular Entities (NMEs) filed either as New Drug Applications (NDAs – small molecules) or original Biologic License Applications (BLAs – therapeutic biologics).  The list of newly approved drugs presented in table 1, includes only drugs that have been approved for the first time, for a first indication. Imaging agents, vaccines and new formulations or combinations of approved drugs were not included.

Continuing the trend from 2011, this is the largest number of approvals since 2004 (figure 1). In contrast, the number of approved innovative biologic therapies, which has been on an upward trend in recent years, is on a 4 year low, with only 4 biologics approved in 2012. 

Of the thirty three approved NMEs listed in table 1, seventeen were developed by Top-20 Pharma companies, either in-house or under agreements with smaller biotechs. Leading the Big Pharma approvals are Pfizer and Teva, with 3 drugs each.

Figure 2, which shows the segmentation of 2012 approved drugs according to therapeutic area, clearly indicates that cancer is by far the most productive therapeutic area in 2012, with 12 out of 33 new drugs targeted at the #2 cause of death worldwide (second to cardiovascular diseases). Interestingly, 7 of the 12 newly approved cancer drugs are protein inhibitors. After oncology-related drugs, the second place goes to drugs that target conditions related to metabolism and endocrinology, with 4 approvals.

Table 1: 2012 FDA approved innovative NMEs

Company	Date of approval	Brand name	Generic name	Indication
Pfizer	Jan-12	Inlyta	Axitinib	Advanced renal cell carcinoma
Vertex Pharmaceuticals	Jan-12	Kalydeco	Ivacaftor	Cystic fibrosis with the G551D mutation in the CFTR gene
LEO Pharma	Jan-12	Picato	Ingenol mebutate	Actinic keratosis
BTG International	Jan-12	Voraxaze	Glucarpidase	Toxic plasma methotrexate concentrations in patients with impaired renal function
Genentech/Curis	Jan-12	Erivedge	Vismodegib	Basal cell carcinoma
BioSante/ Teva Pharmaceuticals	Feb-12	Bio-T-Gel	Testosterone	Hypogonadism
Merck & Co.	Feb-12	Zioptan	Tafluprost	Glaucoma/ocular hypertension.
Discovery Laboratories	Mar-12	Surfaxin	Lucinactant	Prevention of respiratory distress syndrome in premature infants
Affymax/Takeda Pharmaceutical	Mar-12	Omontys	Peginesatide	Anemia due to chronic kidney disease  in adult patients on dialysis
Vivus	Apr-12	Stendra	Avanafil	Erectile dysfunction
Protalix BioTherapeutics	May-12	Elelyso	Taliglucerase alfa	Type 1 Gaucher disease
Astellas Pharma	Jun-12	Myrbetriq	Mirabegron	Overactive bladder
Genentech (Roche)	Jun-12	Perjeta	Pertuzumab	HER2+ metastatic breast cancer
Arena Pharmaceuticals	Jun-12	Belviq	Lorcaserin	Weight loss and maintenance in obese and overweight adults
Forest Labs	Jul-12	Tudorza Pressair	Aclidinium bromide	Bronchospasm associated with chronic obstructive pulmonary disease
Onyx Pharmaceuticals/ Ligand Pharmaceuticals	Jul-12	Kyprolis	Carfilzomib	Multiple myeloma
Amarin	Jul-12	Vascepa	Eicosapentaenoic acid ethyl ester	Severe hypertriglyceridemia
Forest Labs/Ironwood Pharmaceuticals	Aug-12	Linzess	Linaclotide	Irritable bowel syndrome with constipation/idiopathic constipation
Teva Pharmaceuticals	Aug-12	Neutroval	Tbo-filgrastim	Severe neutropenia in patients with non-myeloid malignancies
Gilead Sciences	Aug-12	Stribild	Elvitegravir, Cobicistat, Emtricitabine, Tenofovir disoproxil	HIV-1 infection
Sanofi Aventis	Aug-12	Zaltrap	Ziv-aflibercept	Metastatic colorectal cancer
Company	Date of approval	Brand name	Generic name	Indication
Medivation/Astellas Pharma	Aug-12	XTANDI	Enzalutamide	Metastatic, castration-resistant prostate cancer
Sanofi Aventis	Sep-12	Aubagio	Teriflunomide	Multiple sclerosis
Pfizer	Sep-12	Bosulif	Bosutinib	Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia
Bayer	Sep-12	Stivarga	Regorafenib	Metastatic colorectal cancer
Eisai	Oct-12	Fycompa	Perampanel	Partial-onset seizures with or without secondarily generalized seizures
ThromboGenics	Oct-12	Jetrea	Ocriplasmin	Symptomatic vitreomacular adhesion
Teva Pharmaceuticals	Oct-12	Synribo	Omacetaxine mepesuccinate	Chronic or accelerated phase chronic myeloid leukemia
Pfizer	Nov-12	Xeljanz	Tofacitinib	Moderately to severely active rheumatoid arthritis
Exelixis	Nov-12	Cometriq	Cabozantinib	Medullary thyroid cancer
Ariad Pharmaceuticals	Dec-12	Iclusig	Ponatinib	chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia
GlaxoSmithKline	Dec-12		Raxibacumab	inhalational anthrax due to Bacillus anthracis
Novartis	Dec-12	Signifor	Pasireotide diaspartate	Cushing's disease patients who cannot be helped through surgery.

In addition to approving NMEs, the FDA also grants marketing approval for therapies that are not based on new chemical or biologics entities. Such products may be reformulations and repositioning of formerly approved drugs, combination therapies, etc. The major of such non-innovative therapeutics approved during 2012 are presented in table 2.

Table 2: Major 2012 FDA-approved non-innovative NMEs

Company	Date of approval	Brand name	Generic name	Indication
Amylin Pharmaceuticals/ Alkermes	Jan-12	Bydureon	Exenatide	Type 2 diabetes
INSYS Therapeutics	Jan-12	Subsys	Fentanyl	Breakthrough cancer pain
Sunovion Pharmaceuticals	Jan-12	Zetonna	Ciclesonide	Seasonal/perennial allergic rhinitis.
Corcept Therapeutics	Feb-12	Corlux/ Korlym	Mifepristone	Cushing’s Syndrome
EffRx Pharmaceuticals	Mar-12	Binosto	Alendronate	Osteoporosis
Teva Pharmaceutical	Mar-12	QNASL	Beclomethasone dipropionate	Seasonal/perennial allergic rhinitis.
Aptalis Pharma	Mar-12	Ultresa	Pancrelipase	Exocrine pancreatic insufficiency
Meda Pharmaceuticals	May-12	Dymista	Azelastine/ fluticasone	Seasonal allergic rhinitis.
Digestive Care	May-12	Pertzye	Pancrelipase	Exocrine pancreatic insufficiency
Vivus	Jul-12	Qsymia	Phentermine/ Topiramate	Weight loss and maintenance in obese and overweight adults with weight-related comorbidities
Horizon Pharma/ SkyePharma	Jul-12	RAYOS (Lodotra)	Prednisone	Several inflammatory diseases
Talon Therapeutics	Aug-12	Marqibo	Vincristine sulfate	Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia.
NextWave Pharmaceuticals	Sep-12	Quillivant XR	Methylphenidate	ADHD

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