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FDA Accepts Application for Bayer’s Investigational Hemophilia A Therapy

November 6, 2017
FDA Accepts Application for Bayer’s Hemophilia A Therapy

The U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) submitted by Bayer for BAY 94-9027, the company’s long-acting site-specific PEGylated recombinant factor VIII therapy for the treatment of hemophilia in adolescents and adults 12 years of age and over.

The BLA was submitted in light of positive data yielded from a phase 2/3 clinical study known as PROTECT VIII (PROphylaxis in hemophilia A patienTs via directly pEgylated long-aCTing rFVIII). The multicenter and multinational study was designed to evaluate the efficacy and safety of BAY94-9027 when used on-demand and prophylactically once every seven days, once every five days, or twice per week.

“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, Senior Vice President and Head of Medical Affairs Americas, Bayer. “For more than 25 years, Bayer has been committed to working with the community to support patients and deliver a spectrum of factor VIII products to provide physicians with treatment options for managing their patients with hemophilia A.”

Source: PRNewswire, October 30, 2017