February 4, 2009
For an event that had so much buildup, the positive recommendation from an FDA advisory panel for Eli Lilly's (NYSE: LLY ) drug prasugrel was fairly anticlimactic. But at least Lilly now knows that it's just a matter of time until the anti-clotting agent wins approval.
The drugmaker has been waiting for a decision since June. And once a panel of experts finally convened to sort out what the Food and Drug Administration's reviewers couldn't, they recommended, without exception, that the drug be approved. The unanimity was a little surprising, but the thumbs-up sentiment for the drug wasn't. In its briefing documents to the panel, the FDA had already signaled that it thought the drug worked well.
The panel did say that stroke patients shouldn't be given the drug, nor should people who are likely to undergo open-heart surgery. It wasn't as convinced, though, that doctors needed a warning about not giving it to people older than 75 or weighing less than 130 pounds. That's about the best that Lilly could have hoped for, considering that prasugrel has been shown to cause excessive bleeding in some patients. A more restrictive label would have hurt the drug's chances to compete against Sanofi-Aventis (NYSE: SNY ) and Bristol-Myers Squibb's (NYSE: BMY ) blockbuster Plavix.
As for approval, the slow and underfunded FDA has delayed so many drugs over the past year that I've lost count. Everyone from Pfizer (NYSE: PFE ) to Johnson & Johnson (NYSE: JNJ ) to much smaller Amylin Pharmaceuticals (Nasdaq: AMLN ) has felt the effects of the FDA's lag. Theravance (Nasdaq: THRX ) had a panel meeting about its antibiotic telavancin back in November, and the FDA still hasn't rendered a decision. So even though approval should be a boon for Lilly, the company probably doesn't need to check its mailbox anytime soon.