Bayer Receives FDA Approval for Jivi, New Hemophilia A Treatment With Step-Wise Prophylaxis Dosing Regimen

The following is an excerpt from a press release from Bayer. Read the press release in its entirety here. 

Bayer announced that the U.S. Food and Drug Administration has approved Jivi® for the routine prophylactic treatment of hemophilia A in previously-treated adults and adolescents 12 years of age or older. The initial recommended 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 2/3 PROTECT VIII trial, which demonstrated bleed protection and safety of up to a median of 1.9 years (range of 0-2.6 years).¹ Jivi is the third FDA-approved hemophilia A treatment in Bayer’s Hematology portfolio.
 
Read the press release in its entirety here.