Bayer announced today that the US Food and Drug Administration (FDA) has approved Jivi® (BAY94-9027), the company’s long-acting site-specifically PEGylated recombinant factor VIII therapy for the treatment of hemophilia A in adolescents and adults 12 years of age and over. This treatment has been approved for prophylactic, on-demand and perioperative management of bleeding in this population.
Jivi® is a rFVIII replacement therapy, which has proven to stop or prevent bleeding. It was engineered to have an extended half-life by harnessing proven PEG-technology. Jivi® has a half-life of 17.9 hours that delivers sustained levels in the blood.
The approval of Jivi® is supported by the Phase 2/3 PROTECT VIII trial. This study was a 36-week, international, open label, partially randomized trial, consisting of 126 patients. Part A, evaluated the efficacy and safety for on-demand and prophylactic treatment. Part B, evaluated the efficacy and safety during major surgery.
“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, MD, 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.”
Source: Bayer press release dated August 30, 2018