Bayer’s Biologics License Application (BLA) filing for ‘BAY94-9027′, an investigational treatment for hemophilia A in adults and adolescents ≥12 years, has been accepted by the Food and Drug Administration (FDA).

BAY94-9027 is designed to prolong FVIII activity in the blood while preserving coagulation activity using site-specific technology in which the Polyethylene glycol molecule is consistently attached to the factor VIII protein at a specific site. 

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The BLA submission is based on results from the Phase 2/3 randomized clinical trial, ‘PROTECT VIII,’ which evaluated the safety and efficacy of BAY94-9027 as an on-demand and prophylactic therapy (once every 7 days, once every 5 days, or twice per week) in previously treated patients with severe hemophilia A.

“The filing acceptance for BAY94-9027 by the FDA represents a milestone to Bayer in its commitment to seeking potential treatments to address the unmet needs of people living with hemophilia A,” said Dario Mirski, MD, SVP and Head of Medical Affairs Americas, Bayer. 

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