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.

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.