FDA To Hold February Meeting On Lilly’s Prasugrel
4 CommentsBy Ed Silverman // October 16th, 2008 // 6:01 pm
Members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee have been contacted about their availability for a February panel meeting specifically on prasugrel, sources tell The Pink Sheet. And 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 appears slim to none. A February advisory committee date means it is highly unlikely the FDA will decide on prasugrel before March, the newsletter speculates.
Prasugrel is closely watched because of its blockbuster potential, although the repeated delays also symbolize the FDA’s recent caution. 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.
Why the procrastination? A “serious internal disagreement in FDA has developed over whether to approve the drug,” the Sheet writes.
Granting priority review meant key FDA officials are excited about the drug. But an unnamed party has made a compelling argument against approval. Among issues that appear to have caused the delay - the increase in minor and major bleeding and concerns of related deaths in the prasugrel arm of a key clinical trial, and more cancers discovered in the prasugrel group compared to Plavix, the Sheet writes.
UPDATE: Lilly and its prasurgrel partner, Daiichi Sankyo, issued a late-night 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.
“The FDA can schedule an advisory committee at any time during the review of an application. If one is called, then we will be prepared to participate,” John Alexander, global head of R&D at Daiichi Sankyo.
Doc
About itme the FDA called an advisory meeting on this one.
Doug Bremner MD
Yeah! Are they gonna give it to the welfare cheats as well?
CV MD
Given what we currently know about this new agent, it is understandable if there is a lot of debate going on within the FDA. While there were some clinical benefits shown in the pivotal trial, there were clearly some serious questions as to the ultimate effect of the drug. It appears that the Lilly and Daiichi-Sankyo researchers are now faced with some significant holes in their database. They need to answer the question as to why certain subsets of the population had more bleeding than others. If these patients need less drug, there is no data on the lower dose. If the lower dose is used, will there still be clinical event benefits? We all know that Big Pharma companies have a strong tendency to over-market drugs once they get them approved. Lilly has some major egg on its face regarding Zyprexa and still faces huge fines. In addition, it seems that their new CEO was one of the people responsible for Zyprexa marketing. With their track history, can they be trusted to limit themselves to restricted marketing? There is doubt as Big Pharma continues to go for profits over patients. The public will likely be the ones that suffer and the companies and their executives negotiate the payment of huge fines without admitting wrongdoing and laugh all the way to the bank!
Doc
CV MD,
Good points. Another thing the FDA must really think through on this agent is the following.
No matter how restrictive they may make the label, even including a black box - if necessary, they know many physicians will use the product out of label in patient groups in which it should be restricted.
This expanded use will undoubtedly lead to unecessary serious bleeding and possible death. Does the FDA really need or want that outcome?