Health Canada Approves REBLOZYL® (luspatercept), New Class of Treatment for Adult Patients Living with Myelodysplastic Syndromes

February 16, 2021April 19, 2021 testdev

Canada NewsWire

REBLOZYL®, an erythroid maturation agent, is the first and only of its kind approved for use inCanada

MONTREAL,Feb. 16, 2021/CNW/ – 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.1REBLOZYL®represents a new class of treatment for eligible patients as the first and only approved erythroid maturation agent inCanada.1

Learn more about Myelodysplastic Syndromes (MDS) and REBLOZYL. (CNW Group/Bristol Myers Squibb Canada Co.)

“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 inCanada, 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,2and 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,” saidCindy Anthony, Executive Director, Aplastic Anemia & Myelodysplasia Association ofCanada(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″BristolMyers Squibbis thrilled to provide Canadians with an additional option beyond RBC transfusions to treat MDS-associated anemia,” saidAl 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,” saidHabib 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.”HealthCanada’sapproval 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).1The patients were randomized 2:1 to REBLOZYL®or placebo.1In 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.1About Bristol Myers Squibb CanadaBristol 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, visitwww.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 visitwww.bms.com/ca.About Bristol Myers SquibbBristolMyers Squibbis 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 atBMS.comor follow us onLinkedIn,Twitter,YouTube,FacebookandInstagram.About AcceleronAcceleron 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 Phase1b/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 inthe United States,Europe, andCanadafor 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®inthe United Statesand are also developing luspatercept for the treatment of anemia in patient populations of myelodysplastic syndromes, beta-thalassemia, and myelofibrosis.For more information, please visitwww.acceleronpharma.com. Follow Acceleron on Social Media:@AcceleronPharmaandLinkedIn.References: