Posted by Michael Wonder on 01 Aug 2025
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 haemophilia A or B without inhibitors
31 July 2025 - FDA approval is based on phase 3 trial data (explorer8), which established the safety and efficacy of Alhemo (concizumab-mtci) injection in people 12 years and older with haemophilia A or B without inhibitors.
Novo Nordisk announced today that the US FDA approved Alhemo (concizumab-mtci) injection as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and paediatric patients 12 years of age and older with haemophilia A or B (HA/HB) without inhibitors, expanding on the December 2024 approval for HA/HB with inhibitors.
