Swedish Orphan Biovitrum AB (publ) announced the launch of Elocta(R) (efmoroctocog alfa) in first countries in Europe. Elocta is a recombinant human factor VIII Fc fusion protein with an extended half-life, and is 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 prophylaxis and on-demand treatment of bleeding in people with haemophilia A and can be used for all age groups.

The SmPC recommended prophylactic dose of Elocta is 50 IU/kg every three to five days. The dose may be personalised by the treating physician in the range of 25 to 65 IU/kg depending on the severity of the factor VIII deficiency, the location and frequency of bleeding, and the patient's activity level and clinical condition. Elocta is a fully recombinant fusion protein produced from a human cell line without the addition of human- or animal-derived protein.

The European Commission's approval of Elocta was based on data from the pivotal phase 3 A-LONG clinical study which demonstrated the efficacy, safety and pharmacokinetics of Elocta in previously treated males 12 years of age and older with severe haemophilia A, and from the phase 3 Kids A-LONG clinical study, which demonstrated the efficacy and safety of Elocta in previously treated boys under 12 years of age with haemophilia A.