Biogen and Sobi receive positive opinion from CHMP for Elocta (rFVIIIFc) for the treatment of hemophilia A

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 EU.

The positive opinion was based on results from the pivotal, Phase III 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 III 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 authorization 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, 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 US, Canada, Australia, New Zealand and Japan, where it is approved for the treatment of hemophilia.

“We are committed to bringing meaningful treatment advances to the hemophilia community in Europe and worldwide,” said Birgitte Volck, senior vice president of Development and chief medical officer of Sobi. “We welcome the news of this positive CHMP opinion and look forward to the EC’s forthcoming ELOCTA decision.”