![]() The FDA granted Praxbind® Breakthrough Therapy Designation and the application received Priority Review.5 Praxbind® was approved under an Accelerated Approval Pathway.6 The application included data from healthy volunteers as well as results from an interim analysis of the RE-VERSE AD™ trial (NCT 02104947).2,3,7,8 In the studies, the reversal effects of Praxbind® were evident immediately, within minutes after administration of 5 grams of Praxbind®.2,3,7,8 No procoagulant effect was observed after the administration of Praxbind®.2,3,7 While we anticipate that Praxbind® will be rarely used in clinical practice, the availability of a specific reversal agent has the potential to give physicians and patients added confidence in choosing Pradaxa®.” “With this approval, Boehringer Ingelheim is again leading the evolution of anticoagulation care, as we did with the introduction of Pradaxa®. “We are very pleased to offer Praxbind®, the first specific reversal agent for a novel oral anticoagulant, now approved by the FDA,” said Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. Bourses freeze Patanjali Food’s promoter shares move not to hit functioning, says company
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