EMA validates marketing authorisation application for efanesoctocog alfa for treatment of haemophilia A
Sobi today announced that the European Medicines Agency (EMA) has accepted and validated a marketing authorisation application for efanesoctocog alfa, a new class of high-sustained FVIII developed for the treatment of people with haemophilia A of all age groups. The application is based on data from the pivotal XTEND-1 phase 3 study in adults and adolescents and the XTEND-Kids paediatric study