Sobi’s Elocta Receives Swiss Orphan Drug Designation for Haemophilia A
Swedish Orphan Biovitrum (Sobi) have announced that their haemophilia drug, Elocta, has secured orphan drug designation in Switzerland.
Elocta (rFVIIIFc) is a long-acting recombinant factor VIII Fc fusion protein product candidate to treat patients with haemophilia A.
Haemophilia is an inherited condition that affects the blood’s ability to clot. The most common type of haemophilia is haemophilia A, where patients lack clotting factor FVIII.
A marketing authorisation application for Elocta is currently under review by the European Medicines Agency (EMA).
Sobi produces products for haemophilia, inflammation and genetic diseases. The organisation, along with various partner companies, markets a portfolio of speciality and orphan drugs across Europe, the Middle East, Russia and North Africa.
Sobi and Biogen collaborated on the development and commercialisation of Elocta for haemophilia A. Sobi has final development and commercialisation rights for the drug in their territory, which includes Europe, North Africa, Russia and certain Middle Eastern markets.
Biogen are responsible for developing Elocta, in addition to holding manufacturing and commercialisation rights in North America and all other regions across the globe except in Sobi’s territory.
Elocta is the European trade name for rFVIIIFc, which is also called as Eloctate in the US, Canada, Australia and Japan.