Biogen Idec been boosted by approval in the USA for its haemophilia A treatment Eloctate.
The Food and Drug Administration’s green light for Eloctate, (antihaemophilic factor [recombinant] Fc fusion protein) makes it the first haemophilia A treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding. Approval of the drug, which was co-developed with partner Swedish Orphan Biovitrum (Sobi), is based on data from a trial of 164 patients which demonstrated its effectiveness and no safety concerns were identified.
Biogen chief executive George Scangos said that “the proven ability of Eloctate to provide protection from bleeding episodes with prolonged circulation marks the first significant haemophilia A treatment advance in more than 20 years”. Current treatments must be infused two to three times a week, while Eloctate infusions are every three-to-five days.
The inherited blood clotting disorder, which primarily affects males, is caused by defects in the Factor VIII gene and affects one in every 5,000 males born in the USA.
The Eloctate thumbs-up comes on the back of Biogen and Sobi’s Alprolix (recombinant factor IX Fc fusion protein) getting the green light by the FDA in March for haemophilia B.