Tuesday, March 31, 2009

Saxagliptin: Calendar Management

When’s the best time for FDA to hold the first review of an anti-diabetes drug under the new guidelines calling for a thorough examination of cardiovascular effects?

When all the leading cardiologists are exhausted, deconvened and headed back to their practices after four days at their annual convention of the American College of Cardiology.

FDA’s selection of April 1 as the date for the Endrocrinologic Drugs Advisory Committee review of the NDA for Bristol-Myers Squibb’s saxagliptin (Onglyza) tabs suggests an interesting tactical decision.

All signs prior to the saxagliptin meeting point toward FDA hoping to have a positive first experience with reviews of new diabetes drugs in the post-Avandia guideline era. The FDA advisory committee will review Novo Nordisk’s liraglutide injection on the next day, April 2. As we noted in this earlier post, pre-meeting briefing documents for saxagliptin indicate that the sponsor has adequate and convincing data on cardiovascular safety. It may be as good a candidate as FDA has pending to test the new standards for clinical review.

It would also be convenient for FDA and for its endocrinology advisors not to have a large contingent of querulous cardiologists in the audience to pick holes in the application. That’s where the choice of the review date just following ACC becomes important. Putting the saxagliptin review on a date directly conflicting with ACC might have assured less participation by cardiologists, but that might have been too heavy-handed.

Putting the meeting, instead, right after the convention may more subtly restrict attendance by potential critics. FDA has selected two cardiolgists to attend the saxagliptin meeting as temporary voting members of the advisory committee: University of California-San Francisco’s John Teerlink and Tufts University’s Marvin Konstam.)

FDA has been accused recently (and quite publicly) of trying to stack another advisory committee to avoid dissension. The April 1 choice for saxagliptin may be just fool’s good luck for the agency—or it may be good calendar management.


Anonymous said...

Cole: This is just plain rubbish. Didn't daddy teach you anything about running a publication?

Anonymous said...

why are these so-called experts worn out after their ACC boondoggle? Have you never been to one of these?... it's like being on vacation but on somebody else's dime.