Lilly's Prasugrel: the good news and the bad news

Nov/05/2007 05:32 Filed in: Pharma Business
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Lilly presented data this weekend on their potential rival to Plavix, Prasurgel and although there was some good news there is are also a number of hurdles that may delay approval by the FDA. In the head-to-head study, 9.9% of patients on prasugrel suffered either a heart attack, stroke or death from a cardiovascular cause, compared with 12.1% of those given Plavix, that's the good news since that is a 19% reduction in risk favoring prasugrel. Heart attacks were reduced by 24%, and the rate of clots forming in stents was cut by 52%, favoring prasugrel. On the other hand, major bleeding events occurred in 2.4% of patients on prasugrel, compared with 1.8% on Plavix, a 32% increased risk and that is bad news



There are a number of challenges now facing Lilly with this product:

1. Will the FDA require more clinical trials potentially delaying approval a couple of years or more?

2. Will pharmacy managers and health care providers allow Prasurgel in their formularies when Plavix comes off patent in 2011?

3. Will the FDA approve Prasurgel but require a "black box warning"?



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Given what has been happening with the FDA recently this author feels that the FDA will require Lilly to conduct additional clinical trials on the drug before approval. Some analysts also speculate that the excess bleeding raises enough concern that the FDA could require additional research before granting market approval. "It's nonapprovable without another clinical trial," said Mike Krensavage, an analyst at Raymond James Financial Inc., worried that the finding of a significant increase in fatal bleeding -- 0.4% of prasugrel patients, compared with 0.1% of those on Plavix -- will require more studies. Concern about the drug last month led a Morgan Stanley analyst to lower forecast sales for prasugrel. Yesterday, following the presentation, analysts from Sanford C. Bernstein & Co. followed suit.



If Lilly had to resubmit data to the FDA to get approval for Cialis I just can't see how the FDA would approve Prasurgel without requiring more data as well. Yes there are benefits of this product over Plavix but the FDA has to get this approval right, for if there are issues after this drug is approved you know that the finger will be squarely pointed at the FDA and heads will roll.

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