EC gives nod to haemophilia A treatment Elocta

Swedish Orphan Biovitrum AB (Sobi) and Biogen have announced that the European Commission has approved Elocta (rFVIIIFc) for the treatment of haemophilia A.

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.

“The EC’s approval of Elocta is an important milestone for Sobi, and we hope, the haemophilia community in the UK & Ireland, offering the potential to improve the care of people with haemophilia A,” said Neil Dugdale, General Manager Sobi, UK & Ireland. “Our focus is now to ensure timely and sustainable access to Elocta for people living with haemophilia A.”

Elocta approval ‘signifies a real milestone’

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 Phase 3 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 3 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.

John Pasi, Professor of Haemostasis and Thrombosis, at Barts and the London, Queen Mary, University of London said, “This signifies a real milestone for haemophilia care in UK and Ireland – the beginning of the next generation of therapy for haemophilia A. We can potentially improve care for our patients, both protecting against bleeding and also tailoring treatment to the individual.  As a clinician it’s hugely encouraging to see such positive developments in the treatment options we have at our disposal.”

Sobi and Biogen are collaboration partners in the development and commercialisation of rFVIIIFc for haemophilia A. Last year, Sobi exercised its opt-in right to assume rFVIIIFc’s final development and commercialisation in pre-specified territories, which essentially include Europe, North Africa, Russia and certain countries in the Middle East.  Biogen leads development and manufacturing of the product and holds commercialisation rights in North America and all other regions in the world outside of the Sobi territory.