FDA Approves New Indication for BI’s Pradaxa

The FDA on Monday approved a new indication for Boehringer Ingelheim’s Pradaxa to treat certain patients with deep vein thrombosis and pulmonary embolism, a patch of good news as the drugmaker battles a slew of lawsuits surrounding the blockbuster blood thinner.

The drug can now be used to treat DVT and PE in patients who have been treated with a parenteral anticoagulant for five to 10 days and to reduce the risk of recurrent DVT and PE in patients previously treated, BI said.

The FDA based its approval on results from four Phase III studies that evaluated the safety and efficacy of Pradaxa (dabigatran etexilate mesylate) to treat DVT and PE, the company said.

Pradaxa was originally approved in 2010 as the first oral anticoagulant since warfarin, which was approved in the 1950s. It is intended to reduce stroke risk in patients with nonvalvular atrial fibrillation.
 
The drugmaker is facing hundreds of lawsuits from patients alleging that BI didn’t provide adequate warning of the risk of serious hemorrhaging from using the drug. More than 2,100 lawsuits are pending in the southern district of Illinois, according to the law firm Bernstein Liebhard, which is litigating some of the cases. — Robert King

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