Note: The following is an edited excerpt from a press release from Genentech. To read the press release in it’s entirety, click HERE.
Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved HEMLIBRA庐聽(emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors. In two clinical studies for people with hemophilia A with inhibitors, HEMLIBRA was shown to substantially reduce bleeds in adults and children.
HEMLIBRA will be available to people in the U.S. shortly after approval. Genentech is committed to helping people with hemophilia A with inhibitors access HEMLIBRA and will be offering comprehensive services to help minimize barriers to access and reimbursement. Patients can call (866) HEMLIBRA (436-5427) for more information. For people who qualify, Genentech also plans to offer patient assistance programs through Genentech Access Solutions. More information is available at (866) 4ACCESS/(866) 422-2377 or聽http://www.Genentech-Access
HEMLIBRA was reviewed by the FDA under Priority Review and granted Breakthrough Therapy Designation by the FDA in people 12 years of age or older with hemophilia A with inhibitors in September 2015. Data from HAVEN 1 and HAVEN 2 are being reviewed under accelerated assessment by the European Medicines Agency (EMA) and submissions to health authorities around the world are ongoing.