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Sobi gets Swiss orphan drug designation for Elocta to treat haemophilia A

Swedish Orphan Biovitrum (Sobi) has secured orphan drug designation in Switzerland for its long-acting haemophilia drug candidate Elocta (rFVIIIFc) to treat haemophilia A.

Elocta is a long-acting recombinant factor VIII Fc fusion protein product candidate designed for patients with haemophilia A.

Haemophilia is an inherited condition that regulates the blood’s ability to clot and the most common type of the condition is haemophilia A, where people lack clotting factor FVIII.

Elocta is the European trade name for rFVIIIFc, which is also called as Eloctate in the US, Canada, Australia and Japan, where it is approved to treat haemophilia A.

Currently, a marketing authorisation application (MAA) for Elocta is under review by the European Medicines Agency (EMA).

Sobi and Biogen collaborated on the development and commercialization of Elocta or Eloctate or rFVIIIFc for haemophilia A.

As part of the deal, Sobi has final development and commercialization rights for rFVIIIFc in its territory which includes Europe, North Africa, Russia and certain Middle Eastern markets.

Biogen will be responsible to develop Elocta as well as hold manufacturing and commercialization rights in North America and all other regions across the globe except Sobi territory.