EMA validates marketing authorisation application for efanesoctocog alfa for treatment of haemophilia A,- SOBI + Sanofi
Sobi 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 III study in adults and adolescents and the XTEND-Kids paediatric study in patients less than 12 years of age. Efanesoctocog alfa was approved by the FDA as Altuviiio earlier this year.
Haemophilia A is a rare, genetic disorder in which the ability of a person's blood to clot is impaired due to a lack of factor VIII. Haemophilia A occurs in about one in 5,000 male births annually, and more rarely in females. People with haemophilia can experience bleeding episodes including life-threatening haemorrhages, acute and chronic pain, irreversible joint damage with disability and negative impacts on quality of life. Despite advancements in treatment made in recent years, a large unmet medical need still exists and requires further improvement in the standard of care.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.