FDA approves Jivi a prophylactic treatment for hemophilia A - Bayer HealthCare.
Bayer announced that the FDA has approved Jivi (BAY94-9027) for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older in the U.S. The recommended initial prophylactic regimen for Jivi is twice weekly, with the ability to dose every five days and further individually adjust to less or more frequent dosing based on bleeding episodes. The FDA also approved Jivi for on-demand treatment and the perioperative management of bleeding in the same population.
This approval is based on results from the Phase II/III PROTECT VIII trial. Jivi is the third FDA-approved hemophilia A treatment in Bayer�s hemophilia portfolio. �As a physician who treats hemophilia A patients with a range of individualized needs, Jivi�s approved dosing allows me to adjust frequency based on their bleed episodes to maintain protection from bleeds, which is a serious concern among patients,� said Mark Reding, M.D., PROTECT VIII Lead Investigator and Associate Professor of Medicine at the University of Minnesota. �Jivi is a welcome option that addresses a growing patient need to integrate treatment with personal lifestyles.�
Commenr: The product has a long half-life of 17.9 hours� it consists of a polyethylene glycol polymer attached to recombinant Factor VIII. This allows sustained high levels of Factor VIII and longer coagulation. Traditional products have a half-life of 12 hours.