FDA Drug Approvals on an Uptick

Already in 2017, the FDA has approved a number of new drugs, which Regulatory Focus points out as a trend away from the low number of new drugs approved in 2016. They caution, however, it is unlikely to match the approval highs from 2014 and 2015. The pace for 2017 may not continue at this level and we could see an average, or perhaps slightly above average year for approvals. 2017 vs. Past It has been reported that coming into 2017, the environment was looking better for approvals. According to the FDA’s Office of New Drugs, 36 new molecular entity NDAs were received by FDA through mid-December 2016, already beating the average number of 35 for the past decade. The FDA, which approved 22 treatments last year, has given its approval to 21 drugs so far in 2017 including 3 in May. Key approvals so far in 2017 include Regeneron/Sanofi’s Kevzara (rheumatoid arthritis), Roche’s multiple sclerosis treatment, Ocrevus, Regeneron and Sanofi’s eczema treatment, Dupixent, Tesaro’s PARP inhibitor, Zejula, and BioMarin’s Brineura (treatment of a specific form of Batten disease) among others. Some of these drugs have blockbuster potential. Why the low number in 2016? John Jenkins, the now-retired director of FDA’s Office of New Drugs, offered the explanation that the lower number in 2016 may not be a clear signal that industry innovation is stalling. Jenkins wrote: “For example, CDER approved five novel drugs in 2015 that had PDUFA goal dates in 2016. These early appr...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs