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New drug approvals all but screeched to a halt in 2016, with a measly 22 new OKs after a pair of bountiful years. But the FDA wasted no time in 2017, signing off on 12 drugs in the first quarter alone-besting its record for the same period of any year in recent history.
All told, the agency cleared 46 new molecular entities*-surpassing its 2016 total in June-as well as a handful of key biologics, a new shingles vaccine and a pair of CAR-T therapies for blood cancers.
While the FDA itself has pooh-poohed any suggestions that it has grown more lenient, industry watchers aren’t buying it, EP Vantage wrote in its 2018 Preview. In fact, the agency’s “U-turns” on rigorous safety requirements in drugs, such as Eli Lilly’s rheumatoid arthritis drug Olumiant, and its controversial decision to approve Sarepta’s Duchenne drug Exondys 51 last year are helping drive the perception of a “friendly FDA.”
Novartis and AstraZeneca emerged the clear winners, with three approved therapies each. Pfizer, Roche, Valeant and tandem Sanofi and Regeneron each scored two approvals. Gilead also logged two, if you count Yescarta, picked...