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By Bronwyn Mixter
Jan. 4 — The FDA's Center for Drug Evaluation and Research (CDER) approved 45 novel “new” drugs under new drug applications (NDAs) or biologics license applications (BLAs) in calendar year 2015, according to a report published Jan. 4 on the agency's website.
These drugs are innovative products that serve previously unmet medical needs or otherwise significantly help to advance patient care and public health, the Food and Drug Administration said.
From 2006 through 2014, CDER averaged about 28 new drug approvals per year, the report said.
The report also said that CDER was able to meet or exceed most Prescription Drug User Fee Act (PDUFA) goal dates in 2015. Under PDUFA, sponsors are assessed user fees that give the FDA additional resources to meet certain performance goals. In 2015, CDER met its PDUFA goal dates for 96 percent of the novel new drugs approved (43 of 45), the report said.
The report said 16 of the 45 products approved in 2015 (36 percent) were first-in-class drugs.
“These drugs often have mechanisms of action different from those of existing therapies,” the FDA said. “This first-in-class approval rate is one factor that suggests the 2015 group of novel new approvals is a field comprised of many innovative products.”
About 47 percent of the novel new drugs approved in 2015 (21 of 45) were approved to treat rare or “orphan” diseases that affect 200,000 or fewer Americans, the report said.
“This is significant because patients with rare diseases often have few or no drugs available to treat their conditions,” the agency said. Orphan drug designation provides incentives such as tax credits, user fee waivers and eligibility for orphan drug exclusivity to assist and encourage the development of drugs for rare diseases.
The report said CDER used a number of regulatory methods to expedite drug approvals in 2015, including fast track designation, breakthrough therapy designation, priority review and accelerated approval.
Fourteen of the 2015 new drugs (31 percent) were designated as fast track, meaning drugs with the potential to address unmet medical needs, the report said. Fast track designation speeds new drug development and review, for instance, by increasing the level of communication between the agency and drug sponsors.
CDER also designated 10 of the 2015 novel new drugs (22 percent) as breakthrough therapies, the report said. Breakthrough therapy designation is granted for a drug that is intended to treat a serious condition and when an application for it is submitted, preliminary clinical evidence indicates that it may demonstrate substantial improvement over available therapies.
The report also said 24 of the 2015 novel new drugs (53 percent) were designated priority review. Priority review designation is granted to applications for drugs that show a significant improvement in safety or effectiveness in treating a serious condition.
Also, the report said CDER approved six of the 2015 new drugs (13 percent) under its accelerated approval program. The FDA's accelerated approval program provides earlier patient access to promising new drugs while the sponsor conducts confirmatory clinical trials.
Holly Campbell, a spokeswoman for the Pharmaceutical Research and Manufacturers of America (PhRMA), told Bloomberg BNA in an e-mail that 2015 “was a particularly strong year of innovation for America's biopharmaceutical companies, demonstrating the industry's commitment to advancing the science and developing new treatment options for patients.”
“The 45 novel new medicines approved by the FDA in 2015 give patients important new treatment options and will play a key role in helping patients live longer, healthier lives,” Campbell said. “More than a third of the new medicines approved were first-in-class treatment options—offering a completely new way to treat diseases—and nearly half were for rare conditions.”
Campbell said that among the new drugs “are innovative cancer treatments with the potential to prolong and transform patients’ lives and a new class of cholesterol-lowering treatments.”
“Despite these recent successes, the biopharmaceutical research and development process remains a challenge, as the cost and complexity of developing a new medicine continues to increase alongside the rapid pace of scientific advances,” Campbell said. “In spite of these risks and challenges, America's biopharmaceutical companies are committed to researching new treatments to improve lives and give patients even greater hope for the future.”
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