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Published on 27 June 2016

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Sobi’s Elocta® (rFVIIIFc) approved in Switzerland for the treatment of haemophilia A

Elocta is the only recombinant factor VIII Fc fusion protein with an extended half-life approved for haemophilia A treatment in Switzerland to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days.

Elocta is the only recombinant factor VIII Fc fusion protein with an extended half-life approved for haemophilia A treatment in Switzerland to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days.

The Swiss approval of Elocta is an important milestone for the country’s haemophilia A community, offering the potential to improve the care of people with haemophilia A,” said Krassimir Mitchev, MD, PhD, vice president and medical therapeutic area head of Haemophilia at Sobi. “Our focus is now to ensure timely and sustainable access to Elocta for people living with haemophilia A in Switzerland.”

Elocta is indicated for both on-demand and prophylaxis treatment of people with haemophilia A of all ages. The Swiss 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.



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