European Medicines Agency validates Alprolix marketing authorisation application

26 June 2015  •  Author: Victoria White

Biogen and Swedish Orphan Biovitrum (SOBI) have announced that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for Alprolix.


Alprolix is a recombinant factor IX Fc fusion protein product candidate for the treatment of haemophilia B. This validation signifies the initiation of the EMA’s review process.

The World Federation of Haemophilia global survey conducted in 2013 estimates that approximately 28,430 people are currently diagnosed with haemophilia B worldwide. It is caused by having substantially reduced or no factor IX activity, which is needed for normal blood clotting. People with haemophilia B experience bleeding episodes that cause pain, irreversible joint damage, and life-threatening haemorrhages. Prophylactic infusions of factor IX temporarily replace clotting factors necessary to control bleeding and prevent new bleeding episodes.

Alprolix demonstrates prolonged clotting factor circulation in the body

The MAA includes results from two global, Phase 3 clinical trials examining the efficacy, safety and pharmacokinetics (a measure of the presence of the therapy in a person’s body over time) of Alprolix for haemophilia B: the pivotal B-LONG study for previously treated adults and adolescents, and Kids B-LONG study for previously treated children under age 12.

Alprolix is a recombinant, clotting factor IX therapy and is currently approved for the treatment of haemophilia B in the US, Canada, Japan and Australia. It is the only approved haemophilia B therapy to demonstrate prolonged clotting factor circulation in the body.

“The acceptance of this MAA is an important milestone in our goal to bring this innovative therapy to the European haemophilia community,” said Douglas E. Williams, Ph.D., executive vice president of Research and Development at Biogen. “We look forward to working with European regulators to help people with haemophilia B in Europe realize the benefits that treatment with Alprolix may offer.”

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