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

Jivi’s extended half-life allows for twice-weekly initial dosing and may be adjusted to every five days and further individually adjusted to less or more frequent dosing.

Whippany, N.J., August 30, 2018 – Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Jivi® (BAY94-9027, antihemophilic factor (recombinant) PEGylated-aucl) 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 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 safety of up to a media of 1.9 years (range of 0-2.6 years). Jivi is the third FDA-approved hemophilia A treatment in Bayer’s Hematology profile.

 

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