Health Canada Approves REBLOZYL® (luspatercept), New Class of Treatment for Adult Patients Living with Beta Thalassemia
REBLOZYL® is the first and only erythroid maturation agent approved for use in
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
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
“Alongside our partners at
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
About Bristol Myers Squibb Canada
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
REBLOZYL®Canada Product Monograph.
September 25, 2020.
Anemia Institute for Research & Educationand 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.
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