Elocta is the trade name of rFVIIIFc in Europe and is also called as Eloctate in the US, Canada, and Australia, where it is approved to treat hemophilia A.
Eloctate is the first recombinant clotting factor VIII therapy with prolonged circulation that offers protection from bleeding episodes with the potential for an extended interval between prophylactic injections.
Biogen Idec executive vice-president of Research and Development Douglas Williams said: "The validation of Elocta’s application by the EMA is an important step toward bringing this innovative treatment to people with hemophilia A in Europe.
"Elocta has the potential to protect against bleeding episodes while helping to address the challenge of frequent injections."
The MAA was based on results from the pivotal, Phase III clinical trial, A-LONG that examined the efficacy, safety and pharmacokinetics of rFVIIIFc in males 12 years of age and older with severe hemophilia A and from the Phase III clinical trial, Kids A-LONG that evaluated the efficacy and safety of rFVIIIFc in children with hemophilia A under 12 years of age.
The two firms are collaborators in the development and commercialization of Eloctate/Elocta for hemophilia A.
Under the collaboration, Sobi has an opt-in right to take over final development and commercialization of Elocta for the Sobi territories which include Europe, North Africa, Russia and most Middle Eastern markets.
Development for Eloctate/Elocta is lead by Biogen Idec, which has manufacturing rights and commercialization rights in North America and all other regions in the world excluding the Sobi territories.