Bayer AG filed an application seeking approval for its hemophilia A treatment in Japan.
The application for BAY94-9027 is supported by the PROTECT VIII trial, which showed the drug could protect patients from bleeds when used on a preventive basis once every seven days, once every five days, and twice per week.
BAY94-9027 is a factor VIII replacement therapy with extended half-life and drug circulation in the blood when compared to the current standard of care.
Hemophilia A is a congenital bleeding disorder primarily affecting males. People with hemophilia A may experience prolonged or spontaneous bleeding, especially into the muscles and joints.
Bayer submitted an application for the drug to the U.S. Food and Drug Administration in August and to the European Union in September.