Jivi cleared for hemophilia A treatment

October 10, 2018 0 By CH Unnikrishnan

Jivi (BAY94-9027) has been granted approval for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older in the US.

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, Bayer said.

The FDA also approved Jivi for on-demand treatment and the perioperative management of bleeding in the same population.

The US FDA approval is based on the results of the pivotal Phase 2/3 PROTECT VIII trial comprised of prophylactic dosing, on-demand treatment, and perioperative management in previously treated adults and adolescents 12 years of age or older with severe hemophilia A.

BAY94-9027 was engineered to have an extended half-life by harnessing proven PEG-technology that delivers higher sustained levels of FVIII, which extends the blood’s ability to coagulate for longer. As a site-specific PEGylated FVIII, Jivi has a  half-life of 17.9 hours that delivers sustained levels in the blood.

The FDA also approved Jivi for on-demand treatment and the perioperative management of bleeding in the same population.