Indianapolis, IN - The FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) will review the investigational antiplatelet agent prasugrel for the treatment of ACS patients who are managed with PCI in a hearing on February 3, 2009, the companies developing the drug said today [1].

According to Lilly and Daiichi Sankyo, they will have further discussions with the FDA in preparation for the meeting in just over a month.

The approval process for prasugrel has been far from smooth: in September, the FDA let the review deadline for approval pass, saying it had not completed its review, but crucially gave no indication of when it might decide.

Prasugrel is widely considered the most important drug in Lilly's pipeline; it will be sold under the brand name Effient if approved and is expected to be the first real competitor to clopidogrel (Plavix, Bristol-Myers Squibb).

As widely reported by heartwire, the pivotal trial for prasugrel, TRITON-TIMI 38, showed significantly reduced ischemic events with the new drug compared with clopidogrel, but at the expense of an increase in major bleeding in ACS patients scheduled for PCI. Although prasugrel was granted priority review by the FDA, there is apparently discord between members of the CRDAC about the new drug.

Prasugrel has also just been recommended for approval in the European Union. Earlier this month, the European Medicines Agency adopted a positive opinion on the drug for the prevention of atherothrombotic events in patients who are to undergo PCI for ACS [2,3]. A positive opinion is normally a formality before marketing approval is granted.

Meanwhile, the FDA also said today that it might consider amending the labeling for clopidogrel in light of the studies published last week which found it may not be effective in patients who possess a particular genetic variant, as reported by heartwire.

But, as noted by the Wall Street Journal [4], the differing conclusions of the three trials published last week mean a headache for FDA officials.

Larry Lesko, director of the FDA's office of clinical pharmacology, told the newspaper the agency is in discussions with Bristol-Myers Squibb about updating the label but that any decision will not be straightforward. "What I think we're struggling with is what the label is going to say in light of all the ambiguous data out there."