Bayer HealthCare recently announced that the US Food and Drug Administration has accepted a Biologics License Application for BAY 81-8973, the company’s investigational recombinant factor VIII therapy. Bayer is seeking FDA approval for the therapy under its proposed trade name Kovaltry™, for the treatment of hemophilia A in children and adults.
The application is based on results from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials, which evaluated BAY 81-8973 in adults and children using two- and three-times-per-week prophylaxis dosing regimens. The LEOPOLD Clinical Development Program consists of three multinational clinical trials designed to evaluate the pharmacokinetics, efficacy and safety of BAY 81-8973 in subjects with severe hemophilia A.
“Bayer is committed to continually bringing new therapies to hemophilia A patients who need them,” said David Weinreich, MD, Head, Global Development, Specialty Medicine, Bayer HealthCare Pharmaceuticals. “Today’s milestone represents the next step in that commitment.”
Source: Bayer HealthCare news release dated March 4, 2015
