Bristol Myers Squibb Canada (BMS) and Acceleron Pharma Inc. announced today that Health Canada has approved REBLOZYL® (luspatercept) for the treatment of adult patients with red blood cell (RBC) transfusion-dependent anemia associated with β-thalassaemia. REBLOZYL® is the first and only erythroid maturation agent in Canada, representing a new class of treatment for eligible patients.
“Canadians living with β-thalassaemia, who are often dependent on regular blood transfusions, now have a new treatment option in Reblozyl that may address the underlying issues caused by this serious disorder and can decrease their dependence on blood transfusions,” said Riyad Elbard, TIF Board of Directors Member and President of the Thalassemia Foundation of Canada.
Reblozyl works by regulating late-stage red blood cell maturation to potentially reduce the number of regular red blood cell transfusions. In preclinical studies, the drug demonstrated the ability to address ineffective erythropoiesis by enhancing erythroid maturation, thereby increasing hemoglobin through the production of mature red blood cells.
“As a first-in-class therapy, Reblozyl gives Canadians a new approach to treating transfusion dependent anemia associated with β-thalassaemia,” said Al Reba, General Manager, Bristol Myers Squibb Canada. “Regular red blood cell transfusions can cause abnormally high levels of iron in the blood and organs, potentially causing harm over time. The approval of Reblozyl is part of our commitment to Canadians living with serious blood disorders.”
Health Canada’s approval of Reblozyl is based upon findings from the phase 3, double-blind, randomized, placebo-controlled BELIEVE study, which compared treatment with Reblozyl and best supportive care (BSC) to placebo and BSC in patients with anemia associated with beta-thalassemia requiring regular RBC transfusions. The results demonstrated significantly greater percentage of patients treated with Reblozyl achieving ≥33% reduction from baseline in RBC transfusion burden with a reduction of ≥2 units from Weeks 13-24 as compared to placebo (21.4% vs. 4.5%, P<0.001), primary endpoint.
The results of the BELIEVE trial were published earlier this year in the New England Journal of Medicine.