The FDA periodically likes to give itself a high grade as a top performer. And like any good bureaucracy, it has the numbers to back itself up. But a new presentation by Patrick Frey, the chief of staff in the Office of New Drugs at the agency, has come up with a series of slides that also underscores some important trends in drug R&D.
One of the top snapshots in the slide show highlights a key fact. As of the end of November, active INDs hit 7,020 — and that’s a 14-year high signifying a steady growth since 2004, when the number was 4,361.
Breakthrough therapy designations, with their promise of speedy regulatory responses, have proven to be immensely popular. There have been 529 requests and 192 were granted. Fifty-one percent of that figure on OKs are for oncology and hematology — with a big emphasis on blood cancers — which represents the oncology division’s decision to embrace BTDs under the guidance of Richard Pazdur at a time cancer drug research has boomed.
New FDA commissioner Scott Gottlieb has been encouraging the rest of the agency to do better on this score, holding up oncology as an example of the kind of high performance he’s after.
I’ll add that the 12% of BTDs for antivirals is a noteworthy number, signifying added support at a time of growing need.
Yesterday’s approval of Novo Nordisk’s semaglutide for diabetes brought the year-to-date number of OKs to 41. That’s within striking distance of the 45 new approvals that came through in 2015, which was a current-era high for an agency that hasn’t seen a bigger number since 53 new therapies were approved in 1996. You can track how new drug development swooned, up until just a few years ago.
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