EMA accepts Sobi's efanesoctocog alfa filing
Stockholm-based biotech firm Swedish Orphan Biovitrum (STO: SOBI) has announced that the European Medicines Agency (EMA) has accepted and validated a marketing authorization application for efanesoctocog alfa.
Also known as Sobi, the company describes efanesoctocog alfa as a new class of high-sustained FVIII developed for the treatment of people with hemophilia 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 pediatric study in patients of at least 12 years of age.
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