Prasugrel vote will signal FDA's risk/benefit stance

An FDA advisory committee decision tomorrow on Eli Lilly's blood-thinning drug Prasugrel will be closely studied by developers looking for some insights into how the agency will handle potential blockbusters that are linked to dangerous adverse events.

In a new analysis released on Friday, FDA staffers concluded that the drug is better than Plavix at preventing a heart attack, but can also trigger fatal bleeding. That could make it possible for the FDA to require a label--as well as a post-approval safety study--that would steer the drug to patients most likely to benefit from it and away from patients most likely to suffer a reaction.

The FDA's conclusion sets the stage for the next chapter in the ongoing debate between developers who see an overcautious agency bending over backward to satisfy its critics, who in turn maintain that the FDA has been all too willing to oblige pharma companies looking for an approval.

"This drug application offers the FDA an opportunity to approve an innovative life-saving drug that has known safety issues," the Cleveland Clinic's Steven Nissen (photo) told the Wall Street Journal. The FDA, he adds, "must label it appropriately from the start" so certain patients won't use it.

- read the article from the Wall Street Journal

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