Health Canada Approves REBLOZYL® (luspatercept), New Class of Treatment for Adult Patients Living with Myelodysplastic Syndromes
Montreal – February 16, 2021 – Bristol Myers Squibb Canada (BMS) and Acceleron Pharma Inc. announced today that Health Canada has approved REBLOZYL® (luspatercept for injection) for the treatment of adult patients with transfusion-dependent anemia requiring at least two RBC red blood cell (RBC) units over 8 weeks resulting from very low-to intermediate-risk myelodysplastic syndromes (MDS) who have ring sideroblasts and who have failed or are not suitable for erythropoietin-based therapy.1 REBLOZYL® represents a new class of treatment for eligible patients as the first and only approved erythroid maturation agent in Canada.1
“Those living with MDS are often dependent on regular RBC transfusions. While these transfusions help manage symptoms of anemia, transfusion dependency is very burdensome for patients,” said Dr. Rena Buckstein, MD, FRCPC, Haematologist, associate professor and Head of the Hematology Disease Site Group at Odette Cancer Centre, Sunnybrook Health Sciences Centre. “Treatment options to remedy transfusion dependence are limited once first line therapy fails, so REBLOZYL®, as the only erythroid maturation agent in Canada, provides an important MDS treatment to achieve RBC transfusion independence in a subgroup of patients.”
MDS are a group of cancers which cause limitations in the bone marrow’s ability to produce healthy and mature RBCs,2 and typically occur among older people, and in men more than in women.2
“MDS can significantly impact quality of life; especially for those who are dependent on regular RBC transfusions,” said Cindy Anthony, Executive Director, Aplastic Anemia & Myelodysplasia Association of Canada (AAMAC). “We’re pleased to see an alternative to transfusions available which can help alleviate some of the burden of the disease and support patients.”
REBLOZYL® helps to regulate late-stage RBC maturation in order to potentially reduce the need for RBC transfusions.1
“Bristol Myers Squibb is thrilled to provide Canadians with an additional option beyond RBC transfusions to treat MDS-associated anemia,” said Al Reba, General Manager, Bristol Myers Squibb Canada. “This first-in-class treatment is an example of Bristol Myers Squibb’s commitment to develop innovative therapies for Canadians living with severe blood disorders.”
“Working with our partners at Bristol Myers Squibb, we are excited to help address the needs of Canadians living with MDS,” said Habib Dable, President and Chief Executive Officer of Acceleron. “By targeting the ineffective erythropoiesis associated with MDS, REBLOZYL® represents an important addition for the treatment of patients living with this condition.”
Health Canada’s approval of REBLOZYL® is based upon findings from the phase 3, double-blind, randomized, placebo-controlled MEDALIST study, which involved patients with very low- to intermediate-risk MDS with ring sideroblasts (MDS-RS) requiring regular RBC transfusions (>2 RBC units per 8 weeks).1 The patients were randomized 2:1 to REBLOZYL® or placebo.1 In the trial, results demonstrated significantly greater percentage of patients treated with REBLOZYL® achieving transfusion independence for eight weeks or longer during the first 24 weeks of the trial as compared to placebo (38% vs. 13%, P<0.001) at primary endpoint.1
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 research, development, and commercialization efforts in pulmonary and hematologic diseases. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension (PAH), having reported positive topline results of the PULSAR Phase 2 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. Acceleron is also investigating the potential of its early-stage pulmonary candidate, ACE-1334, which it plans to advance into a Phase 1b/2 trial in systemic sclerosis-associated interstitial lung disease (SSc-ILD) this year.
In hematology, REBLOZYL® (luspatercept-aamt) is the first and only approved 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 the United States and are also developing luspatercept for the treatment of anemia in patient populations of myelodysplastic syndromes, beta-thalassemia, and myelofibrosis.
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1. REBLOZYL® Canada Product Monograph. February 11, 2021.
2. Canadian Cancer Society. Myelodysplastic Syndromes. Available at: https://www.cancer.ca/en/cancer-information/cancer-type/leukemia/leukemia/myelodysplastic-syndromes/?region=on#risk_factors. Accessed January 29, 2021.