The FINANCIAL — Biogen and Swedish Orphan Biovitrum AB (publ) (Sobi) on June 26 announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) of ALPROLIX (rFIXFc), a recombinant factor IX Fc fusion protein product candidate for the treatment of hemophilia B. This validation signifies the initiation of the EMA’s review process.
The MAA includes results from two global, Phase 3 clinical trials examining the efficacy, safety and pharmacokinetics (a measure of the presence of the therapy in a person’s body over time) of ALPROLIX for hemophilia B: the pivotal B-LONG study for previously treated adults and adolescents, and Kids B-LONG study for previously treated children under age 12, according to Biogen.
ALPROLIX is a recombinant, clotting factor IX therapy and is currently approved for the treatment of hemophilia B in the U.S., Canada, Japan and Australia. It is the only approved hemophilia B therapy to demonstrate prolonged clotting factor circulation in the body.
“The acceptance of this MAA is an important milestone in our goal to bring this innovative therapy to the European hemophilia community,” said Douglas E. Williams, Ph.D., executive vice president of Research and Development at Biogen. “We look forward to working with European regulators to help people with hemophilia B in Europe realize the benefits that treatment with ALPROLIX may offer.”
Biogen and Sobi are collaborators in the development and commercialization of ALPROLIX for hemophilia B. Sobi has an opt-in right to assume final development and commercialization of ALPROLIX for the Sobi territories (essentially, Europe, North Africa, Russia and certain Middle Eastern markets). Biogen leads development for ALPROLIX, has manufacturing rights, and has commercialization rights in North America and all other regions in the world excluding the Sobi territories.
“Our collaboration with Biogen remains focused on the goal of transforming the care of people living with hemophilia,” said Birgitte Volck, M.D., Ph.D., senior vice president of Development and chief medical officer of Sobi. “The validation of the ALPROLIX MAA marks a critical regulatory milestone in our continued, collaborative global efforts.”