Lilly and partner Daiichi Sankyo got good news about their blood thinner, prasugrel, from the European Union yesterday. The Committee for Medicinal Products for Human Use (CHMP) gave the drug a positive recommendation. Now the duo just needs to wait the customary two to three months for approval from the European Commission, and they'll be able to begin marketing the drug.
In the U.S., they're still waiting.
The year started out good for the companies, with the Food and Drug Administration giving prasugrel a priority review, which usually shaves four months off the standard 10-month review. But in June the FDA bumped its decision back to late September, and here we sit, almost three months beyond that, without any sign of when a decision might take place.
The only ones smiling in all this are Sanofi-Aventis
The question is, then, does the CHMP recommendation make it more likely that the FDA will approve prasugrel stateside? Unfortunately, it's not clear cut. There are plenty of drugs which were approved by one agency and not the other. Schering-Plough's
With the decision dragging on for so long past the September deadline, my best guess is that there's an internal debate at the FDA over whether the benefits of prasugrel outweigh the side effects -- the drug causes excessive bleeding in some patients. It wouldn't shock me to see the drug sent out to an advisory panel, further delaying any stateside approval.
However, I think prasugrel will eventually get approved, perhaps with a stringent label. Eli Lilly's investors will just have to wait awhile longer. At least they're getting paid well while doing so.