Boehringer Ingelheim took a clear lead in the race to gain an approval for a new blockbuster blood-thinner on Monday when an FDA advisory panel voted to support its application for Pradaxa at the agency. But the experts weren't exactly of one mind on what dosage would be best to use.
The vote in favor of Pradaxa was a resounding nine to zero. But the major point to be decided now is whether Boehringer will have the right to market a 150-mg dose alongside a 110-mg dose, giving it greater ability to grab a larger share of the multibillion-dollar market that awaits a successor to warfarin. While the experts weren't asked to vote on the dose, Reuters reports, four said they supported only the highest dose, while six members voiced their support for both. FDA staffers are pushing for an approval only on a 150-mg dose.
There is general agreement at the FDA so far that Pradaxa would offer a significant improvement over warfarin in preventing strokes. But Boehringer is not the only player in the high-stakes development game. Bayer is teamed with Johnson & Johnson and BMS has partnered with Pfizer in the race to gain an approval on a new blood thinner. A decision on Pradaxa is expected by October 19.