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Home Industry News Biogen and Sobi’s Alprolix accepted for EU regulatory review

Biogen and Sobi’s Alprolix accepted for EU regulatory review

26th June 2015

Biogen and Sobi have announced that the European Medicines Agency has accepted their marketing authorisation application for the new haemophilia B therapy Alprolix.

The recombinant factor IX Fc fusion protein product candidate has been accepted for regulatory review in Europe having already been given the green light in the US, Canada, Japan and Australia.

It is the only approved haemophilia B therapy to demonstrate prolonged clotting factor circulation in the body, and has had its efficacy, safety and pharmacokinetics demonstrated in two global phase III trials.

Biogen and Sobi are collaborators in the development and commercialisation of the drug, with Sobi holding the option to take the lead in Europe, North Africa, Russia and certain Middle Eastern markets, while Biogen handles the launch in other territories.

Dr Douglas Williams, executive vice-president of research and development at Biogen, said: "We look forward to working with European regulators to help people with haemophilia B in Europe realise the benefits that treatment with Alprolix may offer."ADNFCR-8000103-ID-801792468-ADNFCR

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