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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

DateArticle
Apr 17, 2018Approval FDA Provides Full Approval to Praxbind (idarucizumab), Specific Reversal Agent for Pradaxa
Oct 16, 2015Approval FDA Approves Praxbind (idarucizumab) as a Reversal Agent for the Anticoagulant Pradaxa
Apr 23, 2015FDA Grants Priority Review to Boehringer Ingelheim’s Biologics License Application for Idarucizumab
Mar  2, 2015Boehringer Ingelheim Submits BLA to FDA for Idarucizumab, Investigational Specific Reversal Agent for Pradaxa
Dec  8, 2014New Data Show Idarucizumab Reverses Anticoagulant Effects of Dabigatran in Middle-Aged, Elderly and Renally Impaired Volunteers
Nov 18, 2014New Data Show Idarucizumab Restores Wound-Site Formation of Fibrin in Healthy Volunteers Given Pradaxa

Further information

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