Biogen receives EU approval for haemophilia drug Elocta

Biogen has announced that its recombinant factor VIII Fc fusion protein therapy Elocta has been approved in Europe for the treatment of haemophilia A.

The European Commission has approved Elocta, making it the first haemophilia A treatment available in the region to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days.

In phase III trials, the drug has shown its safety and efficacy in adult and paediatric patients alike, and it has already demonstrated its value in routine clinical practice since its approval in the US last year.

The product has been jointly developed by Sobi and is sold under the brand name Eloctate in the US, Canada, Australia, New Zealand and Japan.

Dr Gilmore O'Neill, senior vice-president for 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."

This comes after the European Medicines Agency's Committee for Medicinal Products for Human Use recently recommended its new biosimilar anti-TNF therapy Benepali for EU approval.