Sobi and Biogen’s haemophilia A treatment EU-approved
pharmafile | November 27, 2015 | News story | Sales and Marketing | Biogen, elocta, haemophilia a, sobi
Elocta, the haemophilia A treatment developed by the Swedish Orphan Biovitrum (Sobi) and Biogen, has received European Commission approval as a treatment for haemophilia A.
Elocta, which is 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. It will be available in the first EU countries, including the UK, in early 2016.
Sobi and Biogen are collaboration partners in the development and commercialisation of Elocta. Last year, Sobi exercised its opt-in right to assume the drug’s final development and commercialisation in Europe, North Africa, Russia and certain countries in the Middle East. Biogen leads the development and manufacturing of the product and holds commercialisation rights in North America and all other regions in the world outside of these territories.
“The EC’s approval of Elocta is an important milestone for Sobi, and we hope, the haemophilia community in the UK and Ireland, offering the potential to improve the care of people with haemophilia A,” says Neil Dugdale, general manager of Sobi UK and Ireland. “Our focus is now to ensure timely and sustainable access to Elocta for people living with haemophilia A.”
Elocta is indicated for both on-demand and prophylactic treatment of people with haemophilia A of all ages. The EC approval was based on data from Elocta’s Phase III trial A-LONG, which demonstrated its efficacy and safety and pharmacokinetics in previously-treated males aged 12 years and over with severe haemophilia A. 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, was also part of the regulatory submission.
John Pasi, professor of haemostasis and thrombosis at Barts and the London Queen Mary, University of London, comments: “This signifies a real milestone for haemophilia care in the 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.”
“A recent survey of our members highlighted fewer joint problems, less pain and fewer bleeds as the top three factors people with haemophilia feel would improve their quality of life,” adds Liz Carroll, who is chief executive of the UK Haemophilia Society. “We hope that this new treatment option will be part of helping to make haemophilia a smaller and smaller part of some families lives.”
Joel Levy
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