Posted by Michael Wonder on 20 May 2023
EMA validates marketing authorisation application for efanesoctocog alfa for treatment of haemophilia A
19 May 2023 - Sobi today announced that the 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 in patients <12 years of age.
