He indicated that the United States has granted Sanofi, a French laboratory, the "innovative treatment" designation for a drug candidate to treat hemophilia A. This was announced on Wednesday, June 1. Efanesoctocog Alpha is a coagulation factor that Sanofi and Sobi jointly developed for the treatment hemophilia A. It is used to treat a rare bleeding disorder.
FDA granted this status based on data from the phase III clinical trial, which is the final step before commercialization.
These initial results show that patients suffering from severe haemophilia A can be prevented from bleeding by receiving weekly preventive treatment with epifanesoctocog beta for 52 weeks.
Breakthrough Therapy is a designation that reduces the time it takes to develop and assess promising drugs for serious diseases in the United States. Hemophilia A is a condition that affects boys and causes blood to not clot properly because of a lack in coagulation factor.