Biogen Idec’s new haemophilia drug accepted for EU review

Biogen Idec has announced that its new haemophilia A therapy Elocta has been accepted for European regulatory review.

The European Medicines Agency has validated the marketing authorisation application for the recombinant factor VIII Fc fusion protein product candidate, which was developed through a collaboration with Swedish Orphan Biovitrum.

Data from clinical trials showing the efficacy, safety and pharmacokinetics that the drug can provide for adult and paediatric patients has been included in the application.

If approved, Swedish Orphan Biovitrum has an opt-in right to take over final development and commercialisation of Elocta in Europe, north Africa, Russia and most Middle Eastern markets, with Biogen Idec handling its sales in North America and all other regions in the world.

Dr Douglas Williams, executive vice-president of research and development at Biogen Idec, said: "Elocta has the potential to protect against bleeding episodes while helping to address the challenge of frequent injections."

Last week, the firm announced the appointment of renowned scientists Christopher Henderson and Richard Ransohoff to key roles that will assist its res in the field of neurodegenerative diseases.