The move likely would delay a decision on the new drug until March, according to The Pink Sheet, a weekly publication that covers regulatory action at the FDA and other federal agencies. That would be a blow to Indianapolis-based Lilly, which faces a wave of patent expirations in the next few years and is counting on prasugrel to ease the pain.
Its shares were trading at about $33 early this afternoon, down more than 3 percent on the day.
Lilly submitted the drug for approval late last year and the FDA agreed to a six-month review period. Before the June deadline, regulators delayed their decision another three months. Lilly issued a statement Sept. 26 saying the review still was not complete.
Neither the company nor the agency provided a new timeline for a decision.
But The Pink Sheet reported on its Web site yesterday that the FDA has contacted members of its Cardiovascular and Renal Drugs Advisory Committee about a February meeting to discuss prasugrel. The publication said a "serious internal disagreement ... has developed over whether to approve the drug."
Lilly and drug development partner Daiichi Sankyo Co. Ltd. issued a statement late yesterday saying they have not been notified of any regulatory action or of any decision to have an advisory committee to review prasugrel.
Analysts initially tagged prasugrel with blockbuster potential when it proved better at reducing heart-related deaths than the current leading treatment, Plavix. That drug, made by New York-based Bristol-Myers Squibb Co. and France-based Sanofi Aventis, racked up $8.5 billion last year in sales.
But prasugrel also led to higher rates of bleeding in patients who were older, lighter weight, and who had previously suffered a stroke.
Since those negative side effects were revealed in November, analysts fear the FDA will limit the allowed uses of prasugrel. They have scaled back their sales predictions accordingly.
The Pink Sheet cited several apparent causes for the FDA's slow response, including concerns about bleeding and the incidence of cancer in patients taking prasugrel.
"Daiichi Sankyo and Lilly are engaged in an ongoing dialogue with the FDA," Jennifer Stotka, Lilly's vice president of Global Regulatory Affairs, said in the statement. "We remain confident in the overall benefit-risk profile of prasugrel, and we believe this drug should be approved so that we can bring this valuable treatment option to ... [patients] at risk for further cardiovascular events."