Health Canada Approves REBLOZYL® (luspatercept), New Class of Treatment for Adult Patients Living with Beta Thalassemia
29 Septiembre 2020 - 5:59AM
Business Wire
REBLOZYL® is the first and only erythroid
maturation agent approved for use in Canada
Bristol Myers Squibb Canada (BMS) and Acceleron Pharma Inc.
(NASDAQ:XLRN) announced today that Health Canada has approved
REBLOZYL® (luspatercept) for the treatment of adult patients with
red blood cell (RBC) transfusion-dependent anemia associated with
beta(β)-thalassemia.1 REBLOZYL® is the first and only erythroid
maturation agent in Canada, representing a new class of treatment
for eligible patients.1
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 Riyad Elbard, President, Thalassemia Foundation
of Canada.
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 Al Reba, General Manager, 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.”
“Alongside our partners at Bristol Myers Squibb, we are proud to
help meet the needs of Canadians living with disease-related
anemias,” said Habib Dable, President and Chief Executive Officer
of Acceleron. “REBLOZYL® 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 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 New England Journal of Medicine.
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.
About Acceleron
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 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 North America
and are also developing luspatercept for the treatment of anemia in
patient populations of MDS, beta-thalassemia, and myelofibrosis. In
pulmonary, Acceleron is developing sotatercept for the treatment of
pulmonary arterial hypertension (PAH), having recently presented
positive topline results of the Phase 2 PULSAR 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.
For more information, please visit www.acceleronpharma.com.
Follow Acceleron on Social Media: @AcceleronPharma and
LinkedIn.
References:
- REBLOZYL®Canada Product Monograph. September 25, 2020.
- Anemia Institute for Research & Education and 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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version on businesswire.com: https://www.businesswire.com/news/home/20200929005333/en/
Rachel Yates Lead, Corporate Affairs Bristol Myers Squibb Canada
Rachel.Yates@bms.com Matt Fearer Director, Corporate Communications
Acceleron Pharma mfearer@acceleronpharma.com Lucy Hopkins Account
Executive, Health Edelman Lucy.Hopkins@edelman.com
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