Down the stretch they come. Yesterday the an FDA cardiovascular and renal drug advisory committee unanimously (9-0) recommended that Boehringer Ingelheim's new blood thinning drug, Pradaxa, be approved by the agency. This puts Pradaxa in lead to replace the 60-year+ Coumarin (warfarin) in the treatment of blood clots.
Warfarin is difficult to use and must be monitored. It also is known to cross react with many other medications. Pradaxa (dabigatran) is already approved in Europe to prevent blood clots in patients undergoing joint replacement surgeries.
BI takes the lead in the race for a new warfarin - a race in which it is competing with J&J/Bayer's rivaroxaban, BMS/Pfizer's apixaban, and Merck's betrixaban. The anticlotting market has been estimated by analysts to be worth from $12 B to $20 B by 2021.
BI now has a leg up in the saddle. See WSJ, WSJ Health blog, and Fierce Biotech.
Posted by Bruce Lehr September 21st 2010.
Comments