Bristol-Myers Squibb Company (NYSE: BMY) and Acceleron Pharma
Inc. (NASDAQ: XLRN) today announced the U.S. Food and Drug
Administration’s (FDA) Oncologic Drugs Advisory Committee will hold
a review of Bristol-Myers Squibb’s supplemental Biologics License
Application (sBLA) for the use of Reblozyl® (luspatercept-aamt) in
patients with myelodysplastic syndromes (MDS) at its meeting on
December 18, 2019. Bristol-Myers Squibb is seeking approval of
Reblozyl, an erythroid maturation agent representing a new class of
therapy, for the treatment of adult patients with very low- to
intermediate-risk MDS-associated anemia who have ring sideroblasts
and require red blood cell (RBC) transfusions.
Reblozyl is currently being reviewed by the FDA for an
indication in patients with MDS, and the agency has set a
Prescription Drug User Fee Act (PDUFA), or target action, date of
April 4, 2020 for completion of the review. The agency recently
granted approval of Reblozyl for the treatment of anemia in adult
patients with beta thalassemia who require regular RBC
transfusions. Reblozyl is not indicated for use as a substitute for
RBC transfusions in patients who require immediate correction of
anemia.
Reblozyl is not approved for the treatment of MDS in any
country.
About Anemia in Myelodysplastic
Syndromes
Myelodysplastic syndromes (MDS) are a group of closely related,
but diverse blood cancers in which mutations prevent the bone
marrow stem cells from making healthy blood cells. Most patients
experience severe chronic anemia due to the lack of mature RBCs.
Anemia associated with MDS remains a significant area of unmet need
for these patients, as current treatment options are limited,
consisting primarily of medicines that stimulate the production of
erythropoietin, and regular RBC transfusions. Regular RBC
transfusions can disrupt and diminish a patient’s quality of life
and are associated with an increased risk of iron overload,
transfusion reactions and infections.
Bristol-Myers Squibb: Advancing Cancer
Research
At Bristol-Myers Squibb, patients are at the center of
everything we do. The goal of our cancer research is to increase
quality, long-term survival and make cure a possibility. We harness
our deep scientific experience, cutting-edge technologies and
discovery platforms to discover, develop and deliver novel
treatments for patients.
Building upon our transformative work and legacy in hematology
and Immuno-Oncology that has changed survival expectations for many
cancers, our researchers are advancing a deep and diverse pipeline
across multiple modalities. In the field of immune cell therapy,
this includes registrational chimeric antigen receptor (CAR) T-cell
agents for numerous diseases, and a growing early-stage pipeline
that expands cell and gene therapy targets, and technologies. We
are developing cancer treatments directed at key biological
pathways using our protein homeostasis platform, a research
capability that has been the basis of our approved therapies for
multiple myeloma and several promising compounds in early to
mid-stage development. Our scientists are targeting different
immune system pathways to address interactions between tumors, the
microenvironment and the immune system to further expand upon the
progress we have made and help more patients respond to treatment.
Combining these approaches is key to delivering new options for the
treatment of cancer and addressing the growing issue of resistance
to immunotherapy. We source innovation internally, and in
collaboration with academia, government, advocacy groups and
biotechnology companies, to help make the promise of
transformational medicines a reality for patients.
About Reblozyl
(luspatercept-aamt)
Reblozyl is a first-in-class erythroid maturation agent that
promotes late-stage RBC maturation in animal models. Bristol-Myers
Squibb and Acceleron are jointly developing Reblozyl as part of a
global collaboration. It is currently approved in the U.S. for the
treatment of anemia in adult patients with beta thalassemia who
require regular RBC transfusions. Reblozyl is not indicated for use
as a substitute for RBC transfusions in patients who require
immediate correction of anemia. A Phase 3 trial (COMMANDS) in
erythroid stimulating agent-naïve, lower-risk MDS patients, the
BEYOND Phase 2 trial in adult patients with
non-transfusion-dependent beta thalassemia, and a Phase 2 trial in
myelofibrosis patients are ongoing. For more information, please
visit www.clinicaltrials.gov.
U.S. FDA-APPROVED INDICATIONS FOR
REBLOZYL
REBLOZYL is indicated for the treatment of anemia in adult
patients with beta thalassemia who require regular red blood cell
(RBC) transfusions.
REBLOZYL is not indicated for use as a substitute for RBC
transfusions in patients who require immediate correction of
anemia.
Important Safety Information
WARNINGS AND PRECAUTIONS
Thrombosis/Thromboembolism
Thromboembolic events (TEE) were reported in 8/223 (3.6%)
REBLOZYL-treated patients. TEEs included deep vein thrombosis,
pulmonary embolus, portal vein thrombosis, and ischemic stroke.
Patients with known risk factors for thromboembolism (splenectomy
or concomitant use of hormone replacement therapy) may be at
further increased risk of thromboembolic conditions. Consider
thromboprophylaxis in patients at increased risk of TEE. Monitor
patients for signs and symptoms of thromboembolic events and
institute treatment promptly.
Hypertension
Hypertension was reported in 10.7% (61/571) of REBLOZYL-treated
patients. Across clinical studies, the incidence of Grade 3 to 4
hypertension ranged from 1.8% to 8.6%. In patients with beta
thalassemia with normal baseline blood pressure, 13 (6.2%) patients
developed systolic blood pressure (SBP) >130 mm Hg and 33
(16.6%) patients developed diastolic blood pressure (DBP) >80 mm
Hg. Monitor blood pressure prior to each administration. Manage new
or exacerbations of preexisting hypertension using
anti-hypertensive agents.
Embryo-Fetal Toxicity
REBLOZYL may cause fetal harm when administered to a pregnant
woman. REBLOZYL caused increased post-implantation loss, decreased
litter size, and an increased incidence of skeletal variations in
pregnant rat and rabbit studies. Advise pregnant women of the
potential risk to a fetus. Advise females of reproductive potential
to use effective contraception during treatment and for at least 3
months after the last dose.
ADVERSE REACTIONS
Serious adverse reactions
occurring in 1% of patients included cerebrovascular accident and
deep vein thrombosis. A fatal adverse reaction occurred in 1
patient treated with REBLOZYL who died due to an unconfirmed case
of acute myeloid leukemia (AML).
Most common adverse reactions
(at least 10% for REBLOZYL and 1% more than placebo) were headache
(26% vs 24%), bone pain (20% vs 8%), arthralgia (19% vs 12%),
fatigue (14% vs 13%), cough (14% vs 11%), abdominal pain (14% vs
12%), diarrhea (12% vs 10%) and dizziness (11% vs 5%).
LACTATION
It is not known whether REBLOZYL is excreted into human milk or
absorbed systemically after ingestion by a nursing infant. REBLOZYL
was detected in milk of lactating rats. When a drug is present in
animal milk, it is likely that the drug will be present in human
milk. Because many drugs are excreted in human milk, and because of
the unknown effects of REBLOZYL in infants, a decision should be
made whether to discontinue nursing or to discontinue treatment.
Because of the potential for serious adverse reactions in the
breastfed child, breastfeeding is not recommended during treatment
and for 3 months after the last dose.
Please see full Prescribing Information for REBLOZYL.
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. The Company'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 and development efforts in
hematologic, neuromuscular, and pulmonary diseases. In hematology,
the Company and its global collaboration partner, Bristol-Myers
Squibb, are co-promoting newly approved REBLOZYL
(luspatercept-aamt) in North America for the treatment of anemia in
adult patients with beta thalassemia who require regular red blood
cell transfusions and developing luspatercept for the treatment of
chronic anemia in myelodysplastic syndromes and myelofibrosis.
Acceleron is also advancing its neuromuscular program with ACE-083,
a locally-acting Myostatin+ agent in Phase 2 development in
Charcot-Marie-Tooth disease and is conducting a Phase 2 pulmonary
program with sotatercept in pulmonary arterial hypertension.
For more information, please visit www.acceleronpharma.com.
Follow Acceleron on Social Media: @AcceleronPharma and
LinkedIn.
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, the possibility of unfavorable results from
additional studies involving REBLOZYL, that such product candidate
may not receive regulatory approval for the additional indication
described in this release in the currently anticipated timeline or
at all and, if approved, whether such product candidate for such
additional indication described in this release will be
commercially successful. 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’s 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, 2018, 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, Bristol-Myers Squibb undertakes no obligation to
publicly update or revise any forward-looking statement, whether as
a result of new information, future events, changed circumstances
or otherwise.
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Bristol-Myers Squibb Company media@bms.com
609-252-3345
Media Inquiries: Rose Weldon 215-801-7644
Rose.weldon@bms.com
Investors: Tim Power 609-252-7509
timothy.power@bms.com
Acceleron Pharma Inc. Media:
Matt Fearer, (617) 301-9557 Director, Corporate Communications
Investors: Todd James, IRC, (617)
649-9393 Vice President, Investor Relations and Corporate
Communications or Ed Joyce, 617-649-9242 Director, Investor
Relations
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