FDA Grants Accelerated Approval to BI’s Pradaxa Antidote

The FDA last week granted accelerated approval to the first-ever drug to quickly stop hemorrhaging linked to Boehringer Ingelheim’s Pradaxa.

The approval came one day after a consumer watchdog group slammed the agency’s 2010 approval process for the blockbuster bloodthinner as flawed and dangerous.

Praxbind (idarucizumab), also developed by BI, received priority review status from the FDA in April. Its approval could signal a sea change for Pradaxa, which has struggled with the bleeding issue since it entered the market, including hundreds of lawsuits.

The drug has also faced steep competition from Johnson & Johnson and Bayer’s Xarelto (rivaroxaban), which was approved by the FDA in 2011. — Victoria Pelham