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Bayer Submits Application for Long-Acting FVIII Candidate

September 6, 2017
Bayer Submits Application for Long-Acting FVIII Candidate

Bayer recently announced submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application for BAY 94-9027, the company’s long-acting site-specific PEGylated recombinant factor VIII therapy for the treatment of hemophilia A. The application was submitted in light of positive data yielded from a phase 3 clinical study known as PROTECT VIII (PROphylaxis in hemophilia A patienTs via directly pEgylated long-aCTing rFVIII).

According to a Bayer press release, PROTECT VIII demonstrated that BAY94-9027 “provided good protection” from bleeds when used prophylactically once every seven days, once every five days and twice per week. The investigational therapy was also effective controlling bleeding during surgical procedures. Bayer also reported that BAY94-9027 was effective in treating “all bleeds,” most of which were resolved with one or two infusions.

“Since introducing Kogenate around 25 years ago, Bayer has been committed to continuously improving disease management for people living with hemophilia A,” said Dr. Joerg Moeller, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Development. “The filing of BAY94-9027 brings us one step closer to providing a therapeutic option with additional benefits for patients who decided to have a more active lifestyle.”

Source: Bayer press release dated September 6, 2017