Alhemo Approved for Patients 12 and Older

The U.S. Food and Drug Administration (FDA) has approved Alhemo (concizumab-mtci) injection (60 mg, 150 mg, or 300 mg) as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and adolescents (12 years and older) with hemophilia A or B (HA/HB) without inhibitors. It is not known if Alhemo® is safe and effective in people receiving ongoing immune tolerance induction (ITI) or in children younger than 12 years of age. This new indication builds on the December 2024 approval of Alhemo® for HA/HB patients with inhibitors. 

Source: LA Kelley Communications, Inc., Communique, August 2025