Biogen and Sobi’s Alprolix recommended for EU approval in haemophilia B

Biogen and Sobi have announced that their drug Alprolix has been recommended for European regulatory approval as a treatment for haemophilia B.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that marketing authorisation be granted for the recombinant factor IX Fc fusion protein therapy in this indication.

If approved, it would be among the first therapies in Europe to provide haemophilia B patients with prolonged protection against bleeding episodes with prophylactic dosing intervals.

This positive opinion was based on results from B-LONG and Kids B-LONG, two global phase III clinical trials that demonstrated the efficacy, safety and pharmacokinetics of Alprolix among adult and paediatric patients.

Dr Gilmore O'Neill, senior vice-president for Biogen's drug innovation units, said: "We are proud to work with Sobi to continue bringing to Europe these innovative Fc fusion therapies, which are grounded in the most robust real-world experience of any prolonged circulation factor therapies to date."

This comes after Biogen and Samsung Bioepis last month received European regulatory approval for Benepali, the first biosimilar version of etanercept.