Praxbind Approval History
FDA Approved: Yes (First approved October 16, 2015)
Brand name: Praxbind
Generic name: idarucizumab
Dosage form: Injection
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Reversal Agent for Pradaxa
Praxbind (idarucizumab) is a humanized monoclonal antibody fragment (Fab) indicated as a specific reversal agent for the anticoagulant effect of dabigatran (Pradaxa).Pradaxa is widely used to prevent blood clots and to reduce the risk of stroke in people with a heart rhythm disorder. Some patients who take Pradaxa may need their anticoagulant reversed because they are bleeding or require surgery. Praxbind is the first antidote approved for any of the newer oral anticoagulants like Pradaxa. A study published in the New England Journal of Medicine reported that idarucizumab rapidly reversed the bleeding that can occur with Pradaxa. Praxbind has been classified by the FDA as a breakthrough agent, and was approved under the FDA’s accelerated approval program. Pradaxa, also a BI product, is the first of the warfarin alternative oral anticoagulants to have an approved antidote. Studies are ongoing evaluating reversal agents for Eliquis and Xarelto, the other newer oral anticoagulants in competition with Pradaxa.
Development History and FDA Approval Process for Praxbind
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