Health Canada Approves REBLOZYL® (luspatercept), New Class of Treatment for Adult Patients Living with Beta Thalassemia
Montreal – September 29, 2020 – 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 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<0.001), primary endpoint.
The results of the BELIEVE trial were published earlier this year in the New England Journal of Medicine.
About Bristol Myers Squibb Canada
Bristol Myers Squibb Canada Co. is an indirect wholly-owned subsidiary of Bristol Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb global operations, visit www.bms.com. Bristol Myers Squibb Canada Co. delivers innovative medicines for serious diseases to Canadian patients in the areas of cardiovascular health, oncology, and immunoscience. Bristol Myers Squibb Canada Co. employs close to 400 people across the country. For more information, please visit www.bms.com/ca.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. Acceleron’s leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair.
Acceleron focuses its commercialization, research, and development efforts in hematologic and pulmonary diseases. In hematology, REBLOZYL® (luspatercept-aamt) is the first and only erythroid maturation agent approved in the United States, Europe, and Canada for the treatment of anemia in certain blood disorders. REBLOZYL is part of a global collaboration partnership with Bristol Myers Squibb. The Companies co-promote REBLOZYL in North America and are also developing luspatercept for the treatment of anemia in patient populations of MDS, beta-thalassemia, and myelofibrosis. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension (PAH), having recently presented positive topline results of the Phase 2 PULSAR trial. The Company is currently planning multiple Phase 3 trials with the potential to support its long-term vision of establishing sotatercept as a backbone therapy for patients with PAH at all stages of the disease.
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1. REBLOZYL® Canada Product Monograph. September 25, 2020.
2. Anemia Institute for Research & Education and Thalassemia Foundation of Canada. Guidelines for the Clinical Care of Patients with Thalassemia in Canada. Available at: http://www.thalassemia.ca/wp-content/uploads/Thalassemia-Guidelines_LR.pdf. Accessed September 9, 2020.