FDA Approves Bayer’s Extended Half-Life Hemophilia A Treatment Jivi

Rare Daily Staff

The U.S. Food and Drug Administration approved Bayer’s hemophilia A treatment Jivi for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older. The FDA also approved Jivi for on-demand treatment and the perioperative management of bleeding in the same population.

The initial recommended prophylactic regimen for Jivi is twice weekly with the ability to dose every five days or more based on bleeding episodes.

Hemophilia is a rare, genetic disorder in which the ability of a person’s blood to clot is impaired. People with hemophilia A experience bleeding episodes that can cause pain, irreversible joint damage and life-threatening hemorrhages. Prophylactic injections of factor VIII can temporarily replace the clotting factor that is needed to control bleeding and prevent new bleeding episodes.

The approval is based on results from the phase 2/3 PROTECT VIII trial, which demonstrated bleed protection and safety of up to a median of 1.9 years. Jivi is the third FDA-approved hemophilia A treatment in Bayer’s Hematology 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 lead investigator PROTECT VIII trial 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.”

Jivi works by replacing the reduced or missing factor VIII in adults and adolescents 12 years of age or older with hemophilia A. Jivi has a half-life of 17.9 hours that delivers sustained levels in the blood.

Treatment with Jivi was well tolerated in the majority of adult and adolescent patients in clinical trials. The most frequently reported adverse reactions in previously treated patients 12 years of age or older were headache, cough, nausea, and fever. A FVIII inhibitor was reported in one previously treated adult subject. Repeat testing did not confirm the presence of a FVIII inhibitor.

August 30, 2018
Photo: Mark Reding, associate professor of medicine at the University of Minnesota