Prasugrel’s FDA outlook appears brighter

Next Tuesday the FDA’s Cardiovascular and Renal Drugs Advisory Committee will help decide the fate of prasugrel (Effient), Lilly’s highly anticipated and somewhat controversial antiplatelet drug that many have predicted could be the next clopidogrel.

The FDA has released its briefing documents for the meeting, and the bottom line is that prasugrel’s path to approval…

…appears less bumpy than some had expected. 
On the other hand, the document recommends a boxed warning for the drug. According to a Dow Jones Newswire story, analysts are predicting the drug will receive approval, but only for a narrow indication.

Click here to read the FDA briefing document.

Click here to read Lilly’s briefing document.

Click here to see the list of committee members. 

At least one member, Sanjay Kaul, can be expected to ask some very hard questions about the drug. Temporary voting members include the NHLBI’s Richard Cannon and Michael Domanski. They will be joined by  Marving Konstam and James Udelson from Tufts.

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