For an event that had so much buildup, the positive recommendation from an FDA advisory panel for Eli Lilly's
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
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