Sobi has received market approval by the European Comission for Alprolix, a long-duration protein therapy that protects hemophilia B patients from uncontrolled bleeding.
Its candidate for hemophilia B (Alprolix) was one of the most advanced. Its long term studies have shown good results, with two phase III trials – B-Long with 123 adult patients and Kids B-Long for children under 12.
Now, Alprolix (rFIXFc) has been approved by the European Commission (EC). It will be available in all 28 countries of the EU, where it’s the only treatment of its kind for hemophilia B.
The therapy is a recombinant protein that replaces a clotting factor (IX)- which is not naturally expressed in patients.