Friday, July 18, 2008

Prasugrel: My August Looks Free…and So Does My September

Eli Lilly’s prasugrel team may have some free time on its hands in August and September if FDA’s advisory committee calendar is any indicator.

After FDA extended the priority review deadline of the novel anti-platelet drug by three months on June 23—the deadline was June 26—to September 26, speculation began in earnest around whether the drug would be required to go before the agency’s Cariovascular and Renal Drugs Advisory Committee.

August 19-20 had been tentatively blocked off for a meeting of the Cardio-Renal panel and Wall Street, FDA watchers and industry stakeholders pointed to the dates as a strong possibility for a prasugrel review.

Well, a quick look at FDA’s advisory committee calendar shows the blocks have suddenly disappeared. Moreover, September is completely free of any advisory committee meetings and no new Cardio-Renal meeting has been added to the end of July. We should note that a tentative Peripheral and Central Nervous System Drugs Advisory Committee meeting blocked off for August 6-7 has been postponed.

Do with that what you want. Of course, FDA can add a meeting at any time.

But, if FDA sticks to the extended review deadline and the calendar remains as is, it appears that prasugrel will not go before an advisory committee before a final decision on the application is made. That’s probably a positive sign for Lilly because the committee would have been used to address uncertainties with the application and the postmarket surveillance REMS program.

If, however, FDA adds a meeting in late August or early September, that almost certainly means the prasugrel review will miss another deadline.

A Lilly official says the company still has not been informed by FDA that prasugrel will require an advisory committee review. FDA says there is no Cardio-Renal panel scheduled as of right now. We still think prasugrel will be approved on its first cycle.

We’re not going to rehash our reasoning but you can read it by clicking here and the follow-up is here.

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