prophylactic dosing with Alprolix provides safe and effective protection in people with severe haemophilia B
December 11, 2017- SOBI and Bioverativ on Monday announced the results of a new post-hoc longitudinal analysis demonstrating that individualised dosing with extended half-life therapy, Alprolix, every 14 or more days may be a potential option for people with severe haemophilia B who seek the benefits of protection from a prophylactic therapy with reduced treatment burden. The analysis is being presented in a poster session at the 59th Annual Meeting of the American Society of Hematology (ASH).
Alprolix is a recombinant clotting factor IX therapy developed using Fc fusion technology to prolong circulation in the body. Alprolix has the longest real-world experience of any haemophilia B extended half-life therapy and been studied in more than 150 adult, adolescent, and paediatric patients over three years as part of a robust clinical development programme and an extension study.
Using data from the pivotal Phase 3 B-LONG study in 123 patients with severe haemophilia B, and B-YOND, the long-term extension study of Alprolix that included 93 patients from B-LONG, researchers evaluated long-term outcomes of 22 study participants (adults and adolescents ≥12years) in the individualised treatment group who progressed to long-term prophylactic dosing regimens of 14 days or longer. Data from this longitudinal analysis showed these study participants achieved consistent bleed protection with extended prophylactic dosing intervals for up to three years.
“These data show that individualised prophylactic treatment with Alprolix, starting at weekly or ten day dosing intervals with the possibility to extend to 14 days or longer, has the potential to deliver optimal protection against bleeds for people with haemophilia B,” said Maha Radhakrishnan, M.D., Senior Vice President of Medical at Bioverativ.
