Bayer unit files recombinant Factor VIII product for hemophilia A in Japan

Bayer Yakuhin, the Japanese health care subsidiary of Germany’s Bayer (BAYN: DE), has submitted an application for marketing authorization for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, as a treatment of hemophilia A.

BAY 81-8973 is a full-length recombinant factor VIII which has shown clinical benefit of efficacy when used for prophylaxis twice or three times per week, with standard dosages. Bayer filed for European approval of BAY 81-8973 late last year (The Pharma Letter December 6, 2014).

“With more than two decades of experience in Japan, Bayer has a strong commitment to the hemophilia community”, said Joerg Moeller, a member of the Bayer HealthCare executive committee and head of global development. “The submission of BAY 81-8973 in Japan is an important step forward in our continued efforts to improve treatment options for people with hemophilia A.”

Clinical backing for submission

The submission was based on positive results from three Phase III trials in children, adolescents and adults including a total of 204 subjects. The LEOPOLD II clinical trial demonstrated the superiority of prophylaxis versus on-demand therapy with BAY 81-8973. Results show a 93.3% reduction in median annualized bleeding rate (ABR) in the twice-per-week prophylaxis arm versus on-demand and a 96.7% reduction in the three-times-per-week arm versus on-demand. Patients in this study were randomized between the three treatment arms. The actual median ABRs observed were four bleeds when treated two times per week and two bleeds when treated three times versus 60 in the on-demand group.