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Bristol Myers, Acceleron Pharma Announce Health Canada Approval Of Reblozyl

Bristol Myers Squibb Canada or BMS and Acceleron Pharma Inc. (XLRN) said Tuesday that Health Canada has approved Reblozyl (luspatercept) for the treatment of adult patients with red blood cell (RBC) transfusion-dependent anemia associated with beta-thalassemia.

Reblozyl is the first and only erythroid maturation agent in Canada, representing a new class of treatment for eligible patients.

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.

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.

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.

"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. 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.

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