FDA approves Alhemo® as once-daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with hemophilia A or B (HA/HB) witho

PLAINSBORO, N.J. , July 31, 2025 /PRNewswire/ -- Novo Nordisk announced today that the US Food and Drug Administration (FDA) approved Alhemo ® (concizumab-mtci) injection as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B (HA/HB) without inhibitors, expanding on the December 2024 approval for HA/HB with inhibitors. 1,2,3 Currently, many treatments for HA/HB without inhibitors are administered via intravenous infusions. 2 With this approval, Alhemo ® now offers a subcutaneous injection treatment option for this population. 1

"The FDA approval of an expanded indication for Alhemo ® marks a meaningful step forward for people with hemophilia A or B without inhibitors who are looki