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Bayer receives US FDA approval for new hemophilia A treatment

The US Food and Drug Administration (FDA) has approved Bayer’s 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 with the ability to dose every 5 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). Jivi is the third FDA-approved hemophilia A treatment in Bayer’s Hematology portfolio.

Jivi is a welcome option that addresses a growing patient need to integrate treatment with personal lifestyles. 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 (1.7 BU/mL) was reported in one previously treated adult subject. Repeat testing did not confirm the presence of a FVIII inhibitor. Bayer has also submitted marketing authorization applications for BAY94-9027 for the treatment of hemophilia A in the European Union and Japan.

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