Biogen and Sobi receive EU approval for haemophilia B therapy Alprolix

Biogen and Sobi have announced that their new haemophilia B drug Alprolix has been approved by the European Commission.

The extended half-life therapy has been ratified for the treatment of haemophilia B in all 28 EU member states, and is the only recombinant factor IX Fc Fusion protein therapy offering prolonged protection against bleeding episodes with fewer prophylactic injections.

The efficacy, safety and pharmacokinetics of the drug have been demonstrated in two global phase III trials, including the B-LONG study of adults and adolescents, and the Kids B-LONG study for previously treated children under age 12.

It can be administered with an initial dose every seven days or ten days, with the ability to adjust the dosing interval based on individual response.

Dr Gilmore O'Neill, senior vice-president of drug innovation units at Biogen, said: "We're proud to bring the European haemophilia community one of the first treatment advances in nearly 20 years, and believe the availability of extended half-life therapies in Europe will change the way that many approach treatment."

This comes after Biogen's Zinbryta was recommended for European regulatory approval in the treatment of multiple sclerosis earlier this month.