In the company’s press release, RE-VERSE AD lead investigator Charles Pollack, MD, commented, “The emergence of novel oral anticoagulants, or NOACs, marked a significant advancement in anticoagulation care. In the studies, the reversal effects were evident within minutes after administration of 5 grams of Praxbind, and no procoagulant effect was observed after the administration of Praxbind. The application included data from healthy volunteers, as well as results from an interim analysis of the RE-VERSE AD trial. Praxbind was approved by the FDA under an accelerated approval pathway. The company advised that continued approval for this indication may be contingent upon the results of an ongoing cohort case series study, and that Praxbind will be available from major hospital pharmacy distributors in the United States as soon as possible.Īccording to Boehringer Ingelheim Pharmaceuticals, the FDA granted breakthrough therapy designation for Praxbind and the application received priority review. This indication is approved under accelerated approval based on a reduction in unbound dabigatran and normalization of coagulation parameters in healthy volunteers. recently announced that the US Food and Drug Administration (FDA) granted approval of Praxbind (idarucizumab), which is indicated for patients treated with the company’s Pradaxa (dabigatran etexilate mesylate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. October 19, 2015-Boehringer Ingelheim Pharmaceuticals, Inc.
0 Comments
Leave a Reply. |