We knew the story on the prasugrel delay was big, but maybe not quite this big.
If you hadn’t already heard, it appears a decision by FDA on Eli Lilly/Daiichi Sankyo’s anti-clotting drug won’t come until March 2009 at the earliest. That projection is based on the convening of an FDA advisory committee tentatively being scheduled for February 2009. To read the rest, click here.
How important is prasugrel? Let’s put it this way: the stock of Sanofi-Aventis, partner with Bristol-Myers Squibb on the blockbuster blood thinner Plavix which prasugrel is expected to essentially replace, was up 9.3% at midday.
Lilly and Daiichi put out a joint statement responding to our story. The long and short of what they had to say?
1) The companies are still in discussions with FDA.
2) If FDA chooses to schedule an advisory committee, the companies will be ready for it.
3) The companies believe prasugrel should be approved.
“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,” Daiichi’s global head of R&D John Alexander said in a statement.
“Daiichi Sankyo and Lilly are engaged in an ongoing dialogue with the FDA,” Lilly VP-global regulatory affairs Jennifer Stotka said. “We remain confident in the overall benefit-risk profile of prasugrel, and we believe this drug should be approved.”
Wall Street analysts appear to be most concerned with the cancers discovered in the prasugrel arm. Our very basic understanding is that the presence of tumors can be explained by the fact that they were discovered through enrollment and treatment in the TRITON study, not caused by the drug itself. The reasoning? The onset was too rapid to have been caused by prasugrel. That’s only one perspective, though, so do with that what you will. But there is some resentment out there that Lilly did not visibly disclose—if disclose at all—the cancer issue.
Now, the focus shifts to Lilly’s third quarter earnings call slated for Thursday, October 23, where it’s expected the firm will have to address the prasugrel issues in slightly more detail. Or not.