CHMP recommends Elocta (rFVIIIFc)for treatment of haemophilia A- Biogen + Sobi

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 authorization of Elocta (rFVIIIFc). Elocta is a recombinant factor VIII Fc fusion protein product for the treatment of haemophilia A that, if approved, would be the first haemophilia A treatment with prolonged circulation available in the European Union (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 haemophilia 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 haemophilia 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.

Comment: 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 haemophilia A.