Biogen and SOBI get backing from CHMP for Elocta in hemophilia A

US biotech major Biogen (Nasdaq: BIIB) and Swedish Orphan Biovitrum (STO: SOBI) have received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the marketing authorization of Elocta (rFVIIIFc). SOBI’ shares rose 3.2% to 117.00 Swedish kronor on the news on Friday.

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.

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.