REBLOZYL® is the first and only erythroid maturation agent approved for use in Canada

MONTREAL & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol Myers Squibb Canada (BMS) and Acceleron Pharma Inc. (NASDAQ:XLRN) 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 beta(β)-thalassemia.1 REBLOZYL® is the first and only erythroid maturation agent in Canada, representing a new class of treatment for eligible patients.1

Beta thalassemia is a rare genetic blood disorder characterized by ineffective erythropoeisis, which results in the production of fewer and less healthy RBCs and low levels of hemaglobin.2 Patients living with beta thalassemia are often required to receive regular red blood cell transfusions to support normal growth and development, maintain quality of life and increase life expectancy.2

“Canadians living with beta thalassemia, 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, President, 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.1 In preclinical studies, REBLOZYL® demonstrated the ability to address ineffective erythropoiesis by enhancing erythroid maturation, thereby increasing hemoglobin through the production of mature red blood cells.1

“As a first-in-class therapy, REBLOZYL® gives Canadians a new approach to treating transfusion dependent anemia associated with beta thalassemia,” 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.”

“Alongside our partners at Bristol Myers Squibb, we are proud to help meet the needs of Canadians living with disease-related anemias,” said Habib Dable, President and Chief Executive Officer of Acceleron. “REBLOZYL® ultimately addresses the ineffective erythropoiesis associated with beta thalassemia and is an important advancement in the treatment of patients affected by this serious disorder.”

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.1 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