European Commission approves Elocta (rFVIIIFc) for the treatment of haemophilia A- SOBI + Biogen

Swedish Orphan Biovitrum AB (Sobi) and Biogen announced that the European Commission (EC) has approved Elocta (rFVIIIFc) for the treatment of haemophilia A in all 28 European Union (EU) member states, as well as Iceland, Liechtenstein and Norway. Elocta, a recombinant factor VIII Fc fusion protein with an extended half-life, will be the first haemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days. Elocta is indicated for both on-demand and prophylaxis treatment of people with haemophilia A of all ages.

The EC approval was based on data from Elocta's pivotal, phase III A-LONG clinical study, which demonstrated 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 demonstrated the efficacy and safety of rFVIIIFc in previously treated male children with haemophilia A under 12 years of age. The adverse drug reactions with an incidence of > 0.5 per cent for Elocta were arthralgia, malaise, myalgia, headache and rash.