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Biogen and Sobi's Elocta wins EU approval

First haemophilia A treatment to offer prolonged protection against bleeding
Biogen

Biogen and Sobi have received approval from the European Commission for Elocta for the treatment of haemophilia A.

Elocta (rFVIIIFc) is indicated for both on-demand prophylaxis treatment of people with haemophilia A of all ages.

The EC's approval comes on the back of data from the phase III A-LONG clinical study, which demonstrated the efficacy, safety and pharmacokinetics of Elocta in previousl- treated males aged 12 and older, and the Kids A-LONG study in males aged 12 and under with severe haemophilia A.

Gilmore O'Neill, senior VP of drug innovation units at Biogen, said: “Elocta is the first meaningful treatment advance in haemophilia A in nearly 20 years and reinforces our commitment to improving the care of people with this disease around the world.

“Since the therapy's approval in the United States last year, we have seen the benefits that extended protection against bleeds can offer people with haemophilia A, and we are excited to work with Sobi to make this innovative therapy available to people in Europe.”

Elocta is the first recombinant clotting factor VIII therapy that offers an extended half-life in the body.

Haemophilia A is a rare, chronic, genetic disorder in which the ability of a person's blood to clot is impaired due to missing or reduced levels of protein known as factor VIII.

Elocta will now compete with the likes of Baxter's Advate which forms part of the firm's $4bn-plus haemophilia franchise. Additionally, numerous pipeline treatments are likely to reach the market soon, including Bayer's BAY94-9027 in late-stage development.  

Article by
Nikhil Patel

24th November 2015

From: Regulatory

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