Members of the Food and Drug Administration´s (FDA) Cardiovascular and Renal Drugs Advisory Committee have been contacted regarding their availability for a panel meeting in February for a discussion specifically on Eli Lilly and partner Daiichi Sankyo´s top pipeline drug, anti-coagulant Effient (also known as prasugrel), unnamed sources were quoted by newsletter The Pink Sheet. The agency´s Drug Safety and Risk Management Advisory Committee may also be convened.

The agency has already scheduled a December 10 meeting of the Cardio-Renal advisory committee, but the agenda is set and the likelihood of a change is slim. The newsletter speculates that a February advisory committee date means it is highly unlikely the FDA will decide on Effient (prasugrel) before March.

Many analysts have considered Effient (prasugrel) as the likely successor to Sanofi-Aventis/Bristol-Myers Squibb´s top seller Plavix (clopidogrel).

Eli Lilly submitted prasugrel last December and the FDA designated a six month priority review in February. At the end of June, FDA extended the review by another three months due to extra info given the agency. Then, the FDA missed the September 26 deadline.

In the pivotal comparative clinical trial, Eli Lilly´s prasugrel was shown to be 19 percent more effective in preventing strokes, cardiovascular deaths or non-fatal heart attacks than its rival Plavix, although the prasugrel group of patients were also at a 32 percent higher risk of more severe bleeding than the Plavix group.

According to the newsletter, a “serious internal disagreement in FDA has developed over whether to approve the drug or not.”

Eli Lilly and its prasugrel partner, Daiichi Sankyo, issued a statement saying they have not been notified of any regulatory action for the new drug application (NDA) or of any decision to have an advisory committee to review prasugrel.