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BI's Praxbind US Approval May Boost Pradaxa Sales

 
• By Donna Young

The FDA on Oct. 16 gave privately held Boehringer Ingelheim GmgH the go-ahead to market its humanized monoclonal antibody fragment Praxbind (idarucizumab) under an accelerated approval as an agent to reverse the blood-thinning effects of the company's highly popular anticoagulant Pradaxa (dabigatran) in emergency surgery or urgent procedures or in situations when there's life-threatening or uncontrolled bleeding.

The FDA on Oct. 16 gave privately held Boehringer Ingelheim GmgH the go-ahead to market its humanized monoclonal antibody fragment Praxbind (idarucizumab) under an accelerated approval as an agent to reverse the blood-thinning effects of the company's highly popular anticoagulant Pradaxa (dabigatran) in emergency surgery or urgent procedures or in situations when there's life-threatening or uncontrolled bleeding.

Praxbind is the first drug available in the US to reverse Pradaxa, a direct thrombin inhibitor indicated in the US to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, to treat deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant

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