There had been speculation earlier this week the J&J and Bayer's new blood thinner Xarelto might run into problems with an FDA advisory panel, when some alleged gaps in its safety data with certain heart patients was raised in a memo by FDA reviewers.
Nevertheless, the FDA advisory panel voted 9-2 to recommend the agency approve the drug. Xarelto, if/when approved, will be another drug that replaces the old standard warfarin. It will have competition though from the recently approved Pradaxa from BI and a forthcoming drug from Pfizer and BMS called Eliquis. Eliquis is supposed to have the best clinical data of the three.
Posted by Bruce Lehr Sep 8th 2011.