Praxbind (idarucizumab) is a humanized monoclonal antibody fragment (Fab) indicated in patients treated with Pradaxa® (dabigatran) when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding. Praxbind is approved under the FDAs accelerated approval program, which allows the agency to approve drugs for serious conditions that fill an unmet. This article is a collaboration between MedPage Today and: The FDA has approved the first. Treatment for: Reversal Agent for Pradaxa Idarucizumab reverses the blood-thinning effects of dabigatran. The US Food and Drug Administration (FDA) has granted approval of Boehringer Ingelheim’s Praxbind (idarucizumab). Food and Drug Administration (FDA) approved idarucizumab via the accelerated approval program for two indications: emergency surgery/urgent procedures and in life threatening or uncontrolled bleeding from dabigatran.1,2 Idarucizumab and dabigatran are both developed by Boehringer Ingleheim of Ridgefield, Connecticut. The FDA approval of REZZAYO represents a significant milestone for Cidara, and for patients confronted with difficult-to-treat and often deadly candidemia and invasive candidiasis, said. Pradaxa was previously approved in 2010 for the prevention of stroke. This program allows for expedited approval for drugs that fill a particular unmet medical need. Last updated by Judith Stewart, BPharm on April 7, 2020.įDA Approved: Yes (First approved October 16, 2015)Ĭompany: Boehringer Ingelheim Pharmaceuticals, Inc. FDA has granted accelerated approval to Praxbind (idarucizumab) for the emergency reversal of anticoagulant Pradaxa. Praxbind was approved under the FDA’s accelerated approval program.
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