Deadline clock running on Lilly's next big blockbuster

One of the biggest moves in biopharma this week will turn on the FDA's decision on prasugrel, a blood-clot drug advanced by Eli Lily and Daiichi Sankyo. Analysts pegged the decision as one of the biggest in quite some time for Lilly, which could push its stock up or down by as much as 10 percent once the agency makes its ruling by the September 26 deadline.

With no advisory guidance to work with, though, the analysts are somewhat mystified whether prasugrel's mixed data--demonstrating efficacy for heart ailments but raising worries about bleeding--will win an approval or not. The agency has been tougher to convince recently [1], as it grows more wary of potential drug safety fiascos. If prasugrel does get a green light, the drug is a likely blockbuster on the retail drug market.

"It's hard to call this one," Les Funtleyder, a drug analyst with Miller Tabak & Co., told the Star-Tribune. "The FDA is very cautious these days, and rightfully so. It has taken a very strict view of what it will approve."

- read the report [2] from the Indianapolis Star-Tribune

ALSO: GlaxoSmithKline says that the FDA is still reviewing its clotting drug Promacta. Report [3]

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Biopharma sees tougher FDA approval process [1]