REBLOZYL is claimed to be the only approved erythroid maturation agent for the treatment of anemia in certain blood disorders in the US, Europe, and Canada
Bristol Myers gets Health Canada approval for REBLOZYL. (Credit: allinonemovie from Pixabay.)
Bristol Myers Squibb Canada (BMS) has received approval from Health Canada for Reblozyl (luspatercept) to treat red blood cell (RBC) transfusion-dependent anaemia related to beta thalassemia.
The pharmaceutical firm claimed that Reblozyl, which has been developed in collaboration with biopharmaceutical company Acceleron, is the first and only approved erythroid maturation agent for the treatment of anemia in certain blood disorders in the US, Europe, and Canada.
Bristol Myers Squibb and Acceleron plan to jointly develop Reblozyl for the treatment of anaemia in MDS, beta-thalassemia, and myelofibrosis patients in North America.
Acceleron president and CEO Habib Dable said: “Alongside our partners at Bristol Myers Squibb, we are proud to help meet the needs of Canadians living with disease-related anemias.
“Reblozyl L 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 Canadian approval of Reblozyl is based on results from Phase 3 BELIEVE trial
Beta thalassemia is a rare genetic blood disorder that reduces the production of hemoglobin.Patients often require regular red blood cell transfusions to support normal growth and development, quality of life and enhanced life expectancy.
The Canadian regulatory approval of Reblozyl is based on results from the phase 3, double-blind, randomised, placebo-controlled BELIEVE trial.
The study evaluated treatment with Reblozyl and best supportive care (BSC) compared to placebo and BSC in beta-thalassemia patients, who need regular RBC transfusions.
The trial reached its primary endpoint of significantly greater percentage of patients achieving more than 33% reduction in RBC transfusion burden from baseline, compared to placebo.
Bristol Myers Squibb Canada general manager Al Reba said: “As a first-in-class therapy, Reblozyl gives Canadians a new approach to treating transfusion dependent anemia associated with beta thalassemia.
“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.”