The efficacy and safety of PRAXBIND continues to be evaluated in RE-VERSE AD, a Phase 3 global clinical trial. Accelerated approval for PRAXBIND was granted based on results from Phase I data in healthy volunteers. PRAXBIND is the first and only specific non-vitamin K antagonist oral anticoagulant (NOAC) reversal agent approved for use in emergency situations when immediate reversal of the anticoagulant effect of PRADAXA is required.
The data captured via the RE-VECTO program will help the company better understand the actual usage of PRAXBIND in the clinical practice setting. The emergency situations in which PRAXBIND may be used can vary greatly, such as a car accident requiring emergency surgery or other severe bleeding events. Continued approval for this indication may be contingent upon the results of an ongoing cohort case series study. It is intended for patients treated with PRADAXA when reversal of the anticoagulant effects is needed for emergency surgery or other urgent life-threatening situations, such as a patient with uncontrolled bleeding.Īccording to a company representative, this indication received accelerated approval based on a reduction in unbound dabigatran and normalization of coagulation parameters in healthy volunteers. PRAXBIND is a reversal agent for PRADAXA.
The program, titled RE-VECTO, will gather data to better understand the actual usage of PRAXBIND in clinical settings. By Ed Miseta, Chief Editor, Clinical Leaderįollow Me On Twitter Ingelheim Pharmaceuticals has announced the launch of a global program designed to evaluate the use of its PRAXBIND medicine, which received FDA approval in October 2015.
0 kommentar(er)
