Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO: SOBI) and Biogen (NASDAQ: BIIB) today announced that the European Commission (EC) has approved Alprolix® (rFIXFc), their extended half-life therapy, for the treatment of haemophilia B in all 28 European Union (EU) member states, and maintained its orphan designation. Alprolix is the only recombinant factor IX Fc Fusion protein therapy for haemophilia B to offer people in the EU prolonged protection against bleeding episodes with fewer prophylactic injections.
Alprolix is indicated for both on-demand and prophylaxis treatment of people with haemophilia B in all ages. Prophylactically, it can be administered with an initial dose every seven days or every 10 days with the ability to adjust the dosing interval based on individual response.
“With the approval of Alprolix, people with haemophilia B in the UK and Ireland now have the potential to experience prolonged protection from bleeds with fewer injections,” said Dr Shaw Sorooshian, Medical Director at Sobi. “We are working to make Alprolix available to patients in the UK and Ireland as quickly as possible.”
The EC’s approval of Alprolix was based on results from two global Phase 3 clinical trials that demonstrated the efficacy, safety and pharmacokinetics of Alprolix for haemophilia B: the pivotal B-LONG study for previously treated adults and adolescents, and the Kids B-LONG study for previously treated children under age 12. The adverse drug reactions with an incidence of ≥ 0.5 percent for Alprolix were nasopharyngitis (common cold), influenza, arthralgia (joint pain), upper respiratory tract infection, headache, and hypertension. The majority of these events were judged as not related or likely not related to study drug.
“We are encouraged by Sobi and Biogen’s joint work to deliver longer acting treatments for haemophilia. This is an important moment for the 700 or so people in the UK affected by haemophilia B. With the availability of this longer acting treatment we can be sure that the UK’s standards of care for haemophilia B remain amongst the best in the world,” said Liz Carroll, Chief Executive Officer of The UK Haemophilia Society.
Sobi and Biogen collaborate 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.
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.
About Haemophilia B
Haemophilia B is caused by having substantially reduced or no factor IX activity, which is needed for normal blood clotting.[i] The World Federation of Haemophilia estimates that approximately 28,000 people are currently diagnosed with haemophilia B worldwide.[ii]
People with haemophilia B may experience bleeding episodes in joints and muscles that cause pain, decreased mobility and irreversible joint damage. In the worst cases, these bleeding episodes can cause organ bleeds and life-threatening hemorrhages. Infusions of factor IX temporarily replace clotting factors necessary to resolve bleeding and, when used prophylactically, to prevent new bleeding episodes.1
For more information please contact
Dr Shaw Sorooshian, Medical Director
T: +44 (0) 1628 722380
[i] 1. World Federation of Hemophilia. About Bleeding Disorders – Frequently Asked Questions. Available at: http://www.wfh.org/en/page.aspx?pid=637#Difference_A_B. Accessed on: February 11, 2016.
[ii] 2. World Federation of Hemophilia. Report on the Annual Global Survey 2013. Available at: http://www1.wfh.org/publications/files/pdf-1591.pdf. Accessed on: February 11, 2016.