Biogen receives CHMP backing for European Elocta approval

Biogen has received a recommendation for European regulatory approval of its potentially groundbreaking haemophilia A therapy Elocta.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed the recombinant factor VIII Fc fusion protein product for the treatment of haemophilia A in the EU.

Positive data from the pivotal phase III A-LONG clinical study and the paediatric Kids A-LONG study were used to support the recommendation. A final decision from the European Commission is expected in the coming months.

If approved, it would be the first haemophilia A treatment with prolonged circulation available in the region.

Dr Aoife Brennan, vice-president of haematology and clinical development at Biogen, said: "The CHMP's recommendation to approve Elocta is an important milestone in potentially bringing this innovative therapeutic option to people with haemophilia A across Europe."

The company also has a haemophilia B therapy, Alprolix, that is under European regulatory review.