2012: Banner Year for New Drugs

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Fueled by new cancer therapeutics, last year the annual new molecular and biological entity approval count from the U.S. Food and Drug Administration (FDA) saw its highest year since 1997. One-third of the novel products approved by the FDA’s Center for Drug Evaluation and Research (CDER) are used to treat cancers of the blood, breast, colon, prostate, skin and thyroid.

FDA approved

As part of the U.S. Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER) promotes and protects the health of Americans by assuring that all prescription and over-the-counter drugs are safe and effective. The CDER evaluates all new over-the-counter and prescription drugs, including biological therapeutics and generic drugs, before they are sold.

The 39 novel approvals for 2012 encompass a number of new cancer therapies, including Roche’s Erivedge, the first FDA-approved drug for late-stage basal cell cancer, the most common form of skin cancer, Genentech’s Perjeta, approved for the 20% of breast cancer patients with HER2 positive cancers, and Medivation’s Xtandi, approved for castration-resistant prostate cancer, one of a new class of drugs known as androgen inhibitors, designed to interfere with the ability of testosterone to bind to prostate cancer cells. Testosterone is the male hormone that fuels prostate cancer cell growth. A detailed list of all new approved therapeutics is shown in the table below.

Positron Emission Tomography (PET) is an imaging technique that employs tracer compounds labelled with positron-emitting radionuclides as molecular probes. Once injected into a patient, the tracers are used to track biochemical and physiological processes in living cells. Two new PET tracers were approved in 2012: one for estimation of beta-amyloid neuritic plaque density in adult patients being evaluated for Alzheimer’s Disease and other causes of cognitive decline, and the second to help detect sites of prostate cancer.

Additional novel products approved in 2012 include treatments for cystic fibrosis, HIV, irritable bowel syndrome, vitreomacular adhesion, glaucoma, seizures and rheumatoid arthritis.

FDA approvals 1996-2012

The 39 new drugs and biological products approved by the FDA for 2012 compares with 30 in 2011 and just 21 in 2010. At least 10 of the drugs had fast track status in 2012, which enabled them to be reviewed more quickly. Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose of fast track status is to get important new drugs to the patient earlier.

The rise of targeted therapies was also a significant contributor to the FDA’s ability to reach decisions quickly and efficiently. Genomics technologies today are a drug development tool that radically streamlines drug targeting and enables much more efficient clinical development in the patients most likely to benefit from the drug.

In addition, two novel vaccines were also approved for use in 2012. Novartis’ Flucelvax is a seasonal influenza vaccine produced using cultured animal cells, the first alternative to the lengthy production of conventional flu vaccines in eggs. GSK’s MenHibrix is a combination vaccine for use in infants and toddlers aged 6 weeks to 18 months for prevention of invasive meningococcal disease.

CDER’s Novel Approvals In 2012

Amyvid Diagnostic PET tracer for estimation of beta-amyloid neuritic plaque density in adult patients being evaluated for Alzheimer’s Disease and other causes of cognitive decline Eli Lilly and Company
Aubagio Inhibits the function of specific immune cells that have been implicated in multiple sclerosis Sanofi
Belviq Used together with diet and exercise to treat chronic weight management Arena Pharmaceuticals
Bosulif For the treatment of chronic myelogenous leukemia (CML) Pfizer (Wyeth)
Choline C 11 Diagnostic PET tracer to help detect sites of prostate cancer Mayo Clinic PET Radiochemistry Facility
Cometriq For the treatment of progressive, metastatic medullary thyroid cancer (MTC) Exelixis
Elelyso Enzyme replacement therapy (ERT) for treating type 1 Gaucher disease (a genetic disease in which a fatty substance (lipid) accumulates in cells and certain organs) Protalix/Pfizer
Eliquis Used to reduce the risk of stroke and blood clots in people who have atrial fibrillation (AFib) Bristol-Myers Squibb
Erivedge For the treatment of advanced basal cell carcinoma Roche/Genentech
Fulyzaq For the treatment of diarrhea in HIV/AIDS patients on anti-retroviral therapy Salix Pharmaceuticals
Fycompa For the treatment of partial onset seizures in patients with epilepsy Eisai
Gattex Used to treat adult patients with short bowel syndrome (SBS) who are dependent on parenteral support NPS Pharmaceuticals
Iclusig For the treatment of two rare forms of leukemia Ariad Pharmaceuticals
Inlyta For the treatment of advanced kidney cancer Pfizer
Jetrea Used to treat symptomatic vitreomacular adhesion, an eye condition related to aging that can lead to complications and vision loss ThromboGenics
Juxtapid Used to treat treatment of homozygous familial hypercholesterolemia, an inherited disorder of high LDL (bad) cholesterol Aegerion Pharmaceuticals
Kalydeco For the treatment of cystic fibrosis Vertex Pharmaceuticals
Kyprolis Used to treat patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent Onyx Pharmaceuticals
Linzess For the treatment of irritable bowel syndrome with constipation and for treatment of chronic idiopathic constipation Forest Laboratories
Myrbetriq For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency Astellas Pharma
Used to reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia Sicor Biotech (Teva Pharmaceuticals)
Omontys Erythropoiesis-stimulating agent for treatment of anemia due to chronic kidney disease in adult patients on dialysis Affymax
Perjeta For the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease Genentech
Picato For the topical treatment of actinic keratoses, precancerous growth that develops on sun-damaged skin Leo Pharma
Prepoprik Used to cleanse the colon as a preparation for colonoscopy in adults Ferring Pharmaceuticals
Raxibacumab For the prophylaxis (meaning measures designed to preserve health and prevent the spread of disease) and treatment of inhaled anthrax Human Genome Sciences
Signifor For subcutaneous use for the treatment of adult patients with Cushing’s disease (a condition in which the pituitary gland releases too much adrenocorticotropic hormone) for whom pituitary surgery is not an option or has not been curative Novartis
Sirturo Used as part of combination therapy for adults with multi-drug resistant tuberculosis Janssen Research and Development
Stivarga For treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild-type, an anti-EGFR therapy Bayer HealthCare Pharmaceuticals
Strendra For the treatment of erectile dysfunction Vivus
Stribild For the treatment of HIV-1 infection in adults who are antiretroviral treatment-naive Gilead Sciences
Surfaxin For the prevention of respiratory distress syndrome in premature infants at high risk for RDS Discovery Laboratories
Synribo For the treatment of adults with chronic or accelerated phase chronic myeloid leukemia with resistance and/or intolerance to two or more tyrosine kinase inhibitors Teva Pharmaceuticals
Tudorza Pressair For long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema Forest Laboratories
Voraxaze For the treatment of toxic plasma methotrexate concentrations  in patients with delayed methotrexate clearance due to impaired renal function BTG International
Xeljanz Used to treat adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotraxate Pfizer
Xtandi Used to treat patients with metasatatic castration-resistant prostate cancer who have previously received docetaxel Medivation/Astellas Pharma
Zaltrap Used in combination with FOLFIRI chemotherapy (5-fluorouracil, leucovorin and irinotecan) for treatment of patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen Sanofi-Aventis U.S.
Zioptan Used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension Merck


  1. Are the 90s Back? Oncologists Drove FDA’s 2012 Novel Approval Count to 15-year High. Pharmaceutical Approvals Monthly. Elsevier Business Intelligence. 2013 Jan.
About the Author

Walter Jessen, Ph.D. is a Data Scientist, Digital Biologist, and Knowledge Engineer. His primary focus is to build and support expert systems, including AI (artificial intelligence) and user-generated platforms, and to identify and develop methods to capture, organize, integrate, and make accessible company knowledge. His research interests include disease biology modeling and biomarker identification. He is also a Principal at Highlight Health Media, which publishes Highlight HEALTH, and lead writer at Highlight HEALTH.