Posted by Michael Wonder on 22 Dec 2024
FDA approves Alhemo injection 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 with inhibitors
20 December 2024 - FDA approval is based on data from the pivotal Phase 3 trial (explorer7) establishing the safety and efficacy of Alhemo for daily prevention of bleeds in adults and paediatric patients 12 years of age and older living with haemophilia A or B with 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 with inhibitors, continuing its more than 35 year commitment to those living with rare bleeding disorders.
