REBLOZYL®, an erythroid maturation agent, is
the first and only of its kind approved for use in Canada
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.
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 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 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.
For more information, please visit www.acceleronpharma.com.
Follow Acceleron on Social Media: @AcceleronPharma and
LinkedIn.
Bristol Myers Squibb Cautionary
Statement Regarding Forward-Looking Statements This
press release contains “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the research, development and
commercialization of pharmaceutical products. All statements that
are not statements of historical facts are, or may be deemed to be,
forward-looking statements. Such forward-looking statements are
based on historical performance and current expectations and
projections about our future financial results, goals, plans and
objectives and involve inherent risks, assumptions and
uncertainties, including internal or external factors that could
delay, divert or change any of them in the next several years, that
are difficult to predict, may be beyond our control and could cause
our future financial results, goals, plans and objectives to differ
materially from those expressed in, or implied by, the statements.
These risks, assumptions, uncertainties and other factors include,
among others, whether REBLOZYL (luspatercept) for the additional
indication described in this release will be commercially
successful and that continued approval of such product candidate
for such additional indication described in this release may be
contingent upon verification and description of clinical benefit in
confirmatory trials. No forward-looking statement can be
guaranteed. Forward-looking statements in this press release should
be evaluated together with the many risks and uncertainties that
affect Bristol Myers Squibb Canada or Bristol-Myers Squibb
Company’s (Bristol Myers Squibb) business and market, particularly
those identified in the cautionary statement and risk factors
discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for
the year ended December 31, 2020, as updated by our subsequent
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and
other filings with the Securities and Exchange Commission. The
forward-looking statements included in this document are made only
as of the date of this document and except as otherwise required by
applicable law, neither Bristol Myers Squibb Canada nor Bristol
Myers Squibb undertakes an obligation to publicly update or revise
any forward-looking statement, whether as a result of new
information, future events, changed circumstances or otherwise.
Acceleron Cautionary Statement
Regarding Forward-Looking Statements This press release
contains forward-looking statements about Acceleron’s strategy,
future plans and prospects, including statements regarding the
development and commercialization of REBLOZYL and the potential of
REBLOZYL as a therapeutic drug. The words "anticipate," "believe,"
"could," "estimate," "expect," "goal," "intend," "may," "plan,"
"potential," "project," "should," "target," "will," "would," and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words.
Actual results could differ materially from those included in
the forward-looking statements due to various factors, risks and
uncertainties, including, but not limited to, that REBLOZYL may not
be commercially successful in the additional indication described
in this press release, and that continued approval of REBLOZYL for
such additional indication described in this press release may be
contingent upon verification and description of clinical benefit in
confirmatory trials. These and other risks and uncertainties are
identified under the heading “Risk Factors” included in Acceleron’s
most recent Annual Report on Form 10-K, Quarterly Report on Form
10-Q, and other filings that Acceleron has made and may make with
the SEC in the future.
The forward-looking statements contained in this press release
are based on management's current views, plans, estimates,
assumptions, and projections with respect to future events, and
Acceleron does not undertake and specifically disclaims any
obligation to update any forward-looking statements.
References:
- REBLOZYL® Canada Product Monograph. February 11, 2021.
- 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210216005710/en/
For media requests: 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 Senior Account Executive, Health Edelman
Lucy.Hopkins@edelman.com
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