Results from B-YOND study reinforce long-term clinical profile of Alprolix for the treatment of haemophilia B - Seite 2

"Study participants receiving prophylactic treatment continue to experience low bleeding rates during this long-term study. The B-YOND study plays an important role in helping us understand this therapy's long-term clinical profile and therapeutic value," says Professor John Pasi, Professor of Haemostasis and Thrombosis at Barts and the London, United Kingdom.

---

About Haemophilia B
Approximately 28,500 people are diagnosed with haemophilia B worldwide, according to World Hemophilia federation. Haemophilia B is caused by 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 injections of factor IX temporarily replace clotting factors necessary to control bleeding and prevent new bleeding episodes.

 

About Alprolix (rFIXFc)

Alprolix (rFIXFc) is a long-acting recombinant factor IX Fc fusion protein product candidate for people with haemophilia B. Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein], is the first recombinant, clotting factor therapy with prolonged circulation in the body for adults and children with haemophilia B, approved in the United States, Canada, Australia and Japan. Alprolix was submitted to the European Medicines Agency (EMA) for regulatory approval in Europe in June 2015.

Alprolix was developed by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body). This enables Alprolix to use a naturally occurring pathway to prolong the time the therapy remains in the body. 

About B-YOND
B-YOND is an ongoing long-term study for people with severe haemophilia B who completed the phase 3 pivotal B-LONG or Kids B-LONG studies. The study's primary endpoint is inhibitor development. B-YOND enrolled 116 males, including 93 participants (81 per cent) who completed B-LONG, and 23 children (100 per cent) of those who completed Kids B-LONG. Secondary endpoints of the B-YOND study include ABRs (including spontaneous joint bleeding rates) per participant and treatment exposure days per participant. Additional outcomes are incidence of adverse events and serious adverse events, and evaluation of treatment of a bleeding episode (number of injections, dose per injection).