FDA approved 45 novel new drugs in 2015, the highest number of approvals since 1996 and second-highest ever.
With a flurry of activity in the last two months of the year, FDA approved 45 novel new drugs in 2015 (1), the highest number of approvals since 1996 and second-highest ever (2). “But far more important than quantity is quality-and the valuable new roles many of these drugs can serve in advancing medical care and the health of patients,” said John Jenkins, director of FDA’s Office of New Drugs in the Center for Drug Evaluation and Research (CDER) (3).
The agency approved 87% of the applications on the first cycle of review and met or exceeded the goal dates under the Prescription Drug User Fee Act for all but two of novel new drugs approved. FDA’s expedited pathways for drug approval again proved successful in 2015:
Fourteen drugs were designated by CDER as Fast Track, with the potential to address unmet medical needs.
Ten drugs were designated as Breakthrough therapies, with preliminary clinical evidence demonstrating that the drug may result in substantial improvement on at least one clinically significant endpoint over other available therapies.
Twenty-four drugs were designated Priority Review, in which CDER determined that the drug could potentially provide a significant advance in medical care and set a target to review the drug within six months instead of the standard 10 months.
Six drugs received early approval under the Accelerated Approval program, which allows early approval of a drug for a serious or life-threatening illness that offers a benefit over current treatments.
In addition, 16 new drugs (36% of those approved) were identified by CDER as first-in-class, with mechanisms of action different from those of existing therapies, and 21 new drugs (47% of those approved) were approved to treat rare or “orphan” diseases that affect 200,000 or fewer Americans.
Zurampic (lesinurad) from Ardea Biosciences to treat high blood uric acid levels associated with gout
Uptravi (selexipag) from Actelion Pharmaceuticals to treat pulmonary arterial hypertension
Bridion (sugammadex) from Organon USA to reverse effects of neuromuscular blocking drugs used during surgery
Alecensa (alectinib) from Alexion Pharmaceuticals to treat ALK-positive lung cancer
Kanuma (sebelipase alfa) from Alexion Pharmaceuticals to treat patients with lysosomal acid lipase (LAL) deficiency
Empliciti (elotuzumab) from Bristol-Myers Squibb to treat people with multiple myeloma who have received one to three prior medications
Portrazza (necitumumab) from Eli Lilly to treat patients with advanced (metastatic) squamous non-small cell lung cancer who have not previously received medication specifically for treating their advanced lung cancer
Ninlaro (ixazomib) from Millennium Pharmaceuticals to treat people with multiple myeloma who have received at least one prior therapy
Darzalex (daratumumab) from Janssen Biotech to treat patients with multiple myeloma who have received at least three prior treatments
Tagrisso (osimertinib) from AstraZeneca to treat certain patients with non-small cell lung cancer
Cotellic (cobimetinib) from Genentech to be used in combination with vemurafenib to treat advanced melanoma
Genvoya, a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide, from Gilead Sciences for use as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older
Nucala (mepolizumab) from GlaxoSmithKline for use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older.