Sobi, Biogen’s haemophilia B therapy gets European approval
pharmafile | May 13, 2016 | News story | Medical Communications, Research and Development, Sales and Marketing | Biogen, haemophilia B, orphan designation, regulation, sobi
Sobi (STO: SOBI) and Biogen (Nasdaq: BIIB) on Friday said the European Commission has approved their drug to treat haemophilia B.
The EC has also maintained the orphan designation for Alprolix, which will be available in all 28 European Union countries, the companies said in a joint statement.
Alprolix is indicated for both on-demand and prophylaxis treatment of people with haemophilia B in all ages. The technology enables Alprolix to use a naturally occurring pathway to prolong the time the therapy remains in the body.
Krassimir Mitchev, vice president and medical therapeutic area head of Haemophilia at Sobi, said: “We are working to make Alprolix available in Europe as quickly as possible.”
The EC’s approval of Alprolix was based on results from two global Phase III clinical trials that demonstrated the efficacy, safety and pharmacokinetics of Alprolix for haemophilia B. The adverse drug reactions for Alprolix include nasopharyngitis (common cold), influenza, arthralgia (joint pain), upper respiratory tract infection, headache, and hypertension.
Sobi and Biogen collaborate on the development and marketing of Alprolix for haemophilia B. Sobi has final development and commercialisation rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets).
Alprolix is currently approved for the treatment of haemophilia B in the United States, European Union, Canada, Japan, Australia, New Zealand, and other countries, to provide prolonged protection from bleeds.
Anjali Shukla
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