Bayer Gets FDA Approval for Hemophilia A Drug

Jivi (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) can be prescribed at different dosing frequencies depending on patient needs.

Patients with Hemophilia A are missing factor VIII (FVIII), which is responsible for blood clotting. Recombinant factor VIII (rFVIII) replacement therapy is the standard of care for the treatment of patients with Hemophilia A and has been used successfully for decades. 

Approval by the US Food and Drug Administration (FDA) of a new form of rFVIII therapy from Bayer gives patients access to a treatment that can be integrated with their personal lifestyles and used at different frequencies according to their needs. Jivi (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl), has been approved for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older. 

Site-specific PEGylation gives Jivi a half-life of 17.9 hours, allowing for sustained levels of the drug in the bloodstream. Jivi is recommended to be administered two times per week as a prophylactic regimen but can be given more or less frequently based on bleeding episodes. Jivi is also approved for on-demand treatment and the perioperative management of bleeding. The approval was based on results of 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).

Bayer has also submitted marketing authorization applications for BAY94-9027 for the treatment of hemophilia A in the European Union and Japan.


Emilie Branch

Emilie is responsible for strategic content development based on scientific areas of specialty for Nice Insight research articles and for assisting client content development across a range of industry channels. Prior to joining Nice Insight, Emilie worked at a strategy-based consulting firm focused on consumer ethnographic research. She also has experience as a contributing editor, and has worked as a freelance writer for a host of news and trends-related publications