BI's Pradaxa antidote gets Breakthrough label
Boehringer Ingelheim announced today that its experimental antidote, designed to stop the bleeding for blood thinner agent Pradaxa, has received a Breakthrough Therapy designation from the FDA—making it the first antidote of its kind for this new class of anticoagulants.
BI recently settled 4,000 Pradaxa lawsuits for $650 million. The lawsuits centered on claims that there was no antidote to prevent bleeding-related deaths. FDA stated in November 2012, however, that the bleeding rates associated with Pradaxa were no higher than with warfarin.