Pharmaceutical innovation had a banner year in 2014, as the FDA approved 41 novel drugs and biologics—the largest number in 18 years and a 52% increase from the 27 approved in 2013.
“2014’s field of novel new drugs will offer much to patients in need,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER), wrote in her summary report on 2014 approvals of new molecular entities under New Drug Applications and new therapeutic biologics under Biologics License Applications.“For instance, we approved more orphan drugs for rare diseases [17, or 41%] than in any previous year in our history.”
Ten of the 41 approvals were for biologics—a five-fold increase from 2013—including such new oncology medications as:
Cyramza (ramucirunab), a stomach cancer treatment from Eli Lilly
Keytruda (pembrolizumab), a first-in-class melanoma drug from Merck
Blincyto (blinatumomab), a treatment for a rare form of acute lymphoblastic leukemia.
Last year also marked another record, with more than 50% of the new drug approvals receiving priority review because of their potential to provide improvements over existing therapies.
Those priority reviews were “the highest number since we started keeping track,” wrote Woodcock. In 2014, “more than three times as many drugs compared to [2013] were approved under FDA’s Breakthrough Designation for promising new therapies, and we approved several new antibiotics.”
Drugs designated as breakthroughs comprised 22%, or nine, of the 41 approvals—triple the number approved as breakthroughs in 2013, according to Woodcock. And 66%, or 27, of the 41 drug approvals were designated in one or more expedited development and review methods, such as Fast Track, Breakthrough, Priority Review and/or Accelerated Review.
Among other notable novel drugs receiving FDA approvals were:
Four type 2 diabetes medications and their dosage forms: Farxiga, a tablet from BMS; Tanzeum, an injection from GlaxoSmithKline; Jardiance, a tablet from Boehringer Ingelheim; and Trulicity, an injection from Lilly
Two for idiopathic pulmonary fibrosis: Esbriet, a capsule from InterMune; and Ofev, a capsule from Boehringer Ingelheim
Zykadia, a capsule from Novartis treats patients with three different types of blood cancers
Two hepatitis C medications: Harvoni, a tablet from Gilead; and Viekira Pak, tablets from AbbVie.
Also, 78% of all new drugs gained approval on the first cycle, with three of the biologics receiving FDA approvals well ahead of their Prescription Drug User Fee Act (PDUFA) dates. In fact, CDER met its PDUFA goal dates for 98% of the new drugs (40 of the 41), according to the summary.
The FDA said one measure of its approval efficiency is comparing it to other countries. In 2014, 63%, or 26, of the 41 drugs were first approved in the U.S.
According to the report, “More important than the quantity of novel new drugs approved by CDER in 2014 is their quality, and the important new roles they are serving to advance medical care.”
