BI's Pradaxa antidote gets Breakthrough label

Share this article:

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.

This material may not be published, broadcast, rewritten or redistributed in any form without prior authorization. Your use of this website constitutes acceptance of Haymarket Media's Privacy Policy and Terms & Conditions