
Canadian approval for Reblozyl for transfusion-dependent anaemia in beta-thalassemia patients
pharmafile | September 29, 2020 | News story | Manufacturing and Production, Sales and Marketing | BMS, Canada, Reblozyl
Bristol Myers Squibb and Acceleron have managed to secure regulatory approval in Canada for Reblozyl (luspatercept) for the treatment of red blood cell (RBC) transfusion-dependent anaemia associated with the rare genetic blood disorder beta-thalassemia.
The application was reviewed and authorised by Health Canada, the nation’s drug regulator, making Reblozyl the first erythroid maturation agent to be approved in the country in this indication.
The regulator made the decision based on Phase 3 data that demonstrated that 21.4% of participants receiving Reblozyl combined with best supportive care saw a reduction of at least 33% from baseline in RBC transfusion burden, with a reduction of at least two units in weeks 13 through to 24. This was “significantly” greater than the 4.5% of patients who achieved the same with placebo.
“As a first-in-class therapy, Reblozyl gives Canadians a new approach to treating transfusion-dependent anaemia associated with beta thalassemia,” remarked Al Reba, General Manager at 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.”
Matt Fellows
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