Drugmakers won fewer U.S. Food and Drug Administration approvals this year for medicines that are first of their kind, as more applications were rejected.
Twenty new molecular entities and novel biologics have been cleared so far, compared with 45 in 2015, according to the FDA. The number of treatments cleared by the agency's Center for Drug Evaluation and Research has not sunk that low since 2007, when only 18 new medicines were approved.
Manufacturing problems contributed to the increased number of rejections, according to an analysis by John Jenkins, director of the FDA's Office of New Drugs. Earlier-than-expected decisions on applications in 2015, whose action dates were not expected to occur until this year, also played a role in the drop in approvals, Jenkins wrote.
Unlike in 2015, when cancer medicines dominated the list of approved drugs, the FDA in 2016 cleared a mix of products, including products to treat hepatitis C, psoriasis, asthma, multiple sclerosis, diabetes and Clostridium difficile infections. Seven drugs won approval to treat rare, or orphan, conditions — a third as many as last year, Jenkins said.
The most recent approval was for Pfizer Inc.'s Eucrisa, an ointment used to treat mild to moderate eczema in patients two years or older. That decision came on the day Jenkins released his analysis, adding one more to the 19 he reported Dec. 14 in Washington; the most new medicines CDER has ever approved in a year was 53 in 1996.
The FDA was speedier at approving medicines in 2016, with the overall median time to approval for new drugs and biologics applications at 7.8 months — the lowest it had recorded since 1993, when it stood at 19.1 months, Jenkins pointed out.
The FDA met its deadlines for all but one of the novel medicines approved in 2016 under agreements in which companies paid user fees to assist the agency in reviewing applications.
Jenkins' analysis also showed that 68% of the applications approved in 2016 had been cleared through priority reviews, meaning they qualified for a shorter evaluation period because the FDA had determined that the products would provide a significant improvement in safety and effectiveness of the treatment.
About a third of the approved products also had been granted a breakthrough therapy designation, a status aimed at speeding reviews of promising medicines intended to treat serious conditions.
Jenkins also reported that 84% of the novel drugs approved in 2016 gained those clearances first in the U.S. before any other market.