Following the recent approval of the extended half-life therapy Alprolix by the European Commission for the treatment of haemophilia B, Swedish Orphan Biovitrum AB (publ) (Sobi) announced the first sales of Alprolix in Germany.
"We are pleased that Alprolix has now started to be commercially available to people with haemophilia B in countries across Europe and will continue to work to make this innovative treatment available as quickly as possible in more countries in Europe to people who can benefit from it," said Alan Raffensperger, chief operating officer at Sobi.
Alprolix is the first and only recombinant factor IX Fc Fusion protein therapy for haemophilia B in the EU, offering people with haemophilia prolonged protection against bleeding episodes. It is indicated for both on-demand and prophylaxis treatment of people with haemophilia B of all ages. Alprolix may be administered prophylactically with an initial dose every seven days or 10 days with the ability to adjust the dosing interval based on individual response.
Alprolix is a recombinant clotting factor therapy developed for haemophilia B by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body). This technology enables Alprolix to use a naturally occurring pathway to prolong the time the therapy remains in the body. While Fc fusion has been used for more than 15 years, Sobi and Biogen are the first companies to utilise it in the treatment of haemophilia.
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. As with any infused protein, allergic type hypersensitivity reactions and development of inhibitors may occur following administration of Alprolix.
Sobi and Biogen collaborated on the development and commercialisation 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). Biogen leads development and manufacturing for Alprolix and has commercialisation rights in North America and all other regions in the world excluding the Sobi territory.