25 September 2015 - Biogen and Swedish Orphan Biovitrum AB (Sobi) received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the marketing authorisation of Elocta (rFVIIIFc). Elocta is a recombinant factor VIII Fc fusion protein product for the treatment of hemophilia A that, if approved, would be the first hemophilia A treatment with prolonged circulation available in the European Union (EU).

The positive opinion was based on results from the pivotal, Phase 3 A-LONG clinical study, which examined the efficacy, safety and pharmacokinetics of rFVIIIFc in previously treated males 12 years of age and older with severe hemophilia A, and from the Phase 3 Kids A-LONG clinical study, which evaluated the efficacy and safety of rFVIIIFc in previously treated male children with hemophilia A under 12 years of age. The Committee’s positive opinion is now referred to the European Commission (EC), which grants marketing authorisation for medicines in the EU.

“The CHMP’s recommendation to approve Elocta is an important milestone in potentially bringing this innovative therapeutic option to people with hemophilia A across Europe,” said Aoife Brennan, M.D, vice president of Hematology, Clinical Development at Biogen. “The potential of Elocta to provide protection against bleeding episodes with fewer prophylactic infusions will, if approved, represent the first treatment advance in nearly 20 years for Europe’s hemophilia community.”

Elocta is the European trade name for rFVIIIFc, which is also known as Eloctate [Antihemophilic Factor (Recombinant), Fc Fusion Protein] in the U.S., Canada, Australia, New Zealand and Japan, where it is approved for the treatment of hemophilia A. Commonly reported adverse drug reactions (>/= 1% of subjects) in the clinical studies were arthralgia, malaise, myalgia, headache and rash. Development of Factor VIII neutralizing antibodies (inhibitors) may occur following administration of Elocta.

For more details, go to: http://media.biogen.com/press-release/investor-relations/biogen-and-sobi-receive-positive-opinion-chmp-elocta-rfviiifc-treat