Posted by Michael Wonder on 25 Jul 2025
European regulatory authority adopts positive opinion for Novo Nordisk’s Alhemo (concizumab), recommending label expansion to treat haemophilia A and B without inhibitors
25 July 2025 - This positive opinion by the EMA’s CHMP is based on results from the explorer8 trial, which showed that Alhemo reduced spontaneous and traumatic bleeds for patients living with haemophilia A and B without inhibitors compared with no prophylaxis.
Novo Nordisk today announced that the EMA’s CHMP has adopted a positive opinion, recommending an update of the Alhemo (concizumab) label to include the treatment of severe haemophilia A and moderate or severe haemophilia B without inhibitors.
