Posted by Michael Wonder on 30 Aug 2018
Bayer receives US approval for modern haemophilia A treatment Jivi with a step-wise prophylaxis dosing regimen
30 August 2018 - Jivi’s extended half-life allows for twice-weekly initial dosing / May be adjusted to every five days and further individually adjusted to less or more frequent dosing.
Bayer announced today that the US FDA has approved Jivi (BAY94-9027) for the routine prophylactic treatment of haemophilia 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 peri-operative management of bleeding in the same population.
This approval is based on results from the Phase 2/3 PROTECT VIII trial. Jivi is the third FDA-approved haemophilia A treatment in Bayer’s haemophilia portfolio.
