Applications supported by positive results
from the pivotal Phase 3 POETYK-PSO clinical trial program
demonstrating superior efficacy of deucravacitinib over Otezla®
(apremilast) and placebo in treating adults with moderate to severe
plaque psoriasis
U.S. Food and Drug Administration assigned a
target action date of September 10, 2022; European Medicines Agency
validation confirms the submission is complete and begins the
centralized review process
Deucravacitinib, an oral, selective tyrosine
kinase 2 (TYK2) inhibitor, would be the first TYK2 inhibitor
approved for the treatment of any disease
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S.
Food and Drug Administration (FDA) has accepted the New Drug
Application (NDA) and the European Medicines Agency (EMA) has
validated the Marketing Authorization Application (MAA) for
deucravacitinib for the treatment of adults with moderate to severe
plaque psoriasis. The FDA has assigned a Prescription Drug User Fee
Act (PDUFA) goal date of September 10, 2022. These latest
regulatory milestones are in addition to the NDA acceptance by
Japan's Ministry of Health, Labour and Welfare for deucravacitinib
for the treatment of adults with moderate to severe plaque
psoriasis, pustular psoriasis and erythrodermic psoriasis.
“There is a strong need for more effective and well-tolerated
oral therapies for people living with moderate to severe plaque
psoriasis, as many remain undertreated or even untreated,” said
Jonathan Sadeh, M.D., MSc., senior vice president of Immunology and
Fibrosis Development, Bristol Myers Squibb. “Findings from the
pivotal POETYK-PSO trials demonstrate the potential of
deucravacitinib to elevate the oral standard of care for
individuals who are candidates for systemic therapy. We look
forward to continuing to work with the FDA and EMA with the goal of
bringing deucravacitinib to patients and physicians as quickly as
possible.”
The regulatory applications are based on positive results from
the pivotal POETYK PSO-1 and POETYK PSO-2 trials, which evaluated
once daily deucravacitinib in patients with moderate to severe
plaque psoriasis versus placebo and Otezla® (apremilast).
Deucravacitinib demonstrated significant and clinically meaningful
improvements in skin clearance, symptom burden and quality of life
measures compared to placebo and Otezla. Deucravacitinib was
well-tolerated with a low rate of discontinuation due to adverse
events, with no clinically meaningful lab abnormalities. Primary
results were presented at the American Academy of Dermatology
Virtual Meeting Experience in April 2021, and additional analyses
were presented at the European Academy of Dermatology and
Venereology 30th Anniversary Congress in September 2021.
Bristol Myers Squibb thanks the patients and investigators
involved in the POETYK-PSO clinical trial program.
About Deucravacitinib
Deucravacitinib (pronounced doo-krav-a-sih-ti-nib) is a
first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor
with a unique mechanism of action and is the first and only
selective TYK2 inhibitor in clinical studies across multiple
immune-mediated diseases. Bristol Myers Squibb scientists designed
deucravacitinib to selectively target TYK2, thereby inhibiting
signaling of interleukin (IL)-23, IL-12 and Type 1 interferon
(IFN), key cytokines involved in the pathogenesis of multiple
immune-mediated diseases. Deucravacitinib achieves a high degree of
selectivity by binding to the regulatory domain of TYK2, resulting
in allosteric inhibition of TYK2 and its downstream functions.
Deucravacitinib selectively inhibits TYK2 at physiologically
relevant concentrations. At therapeutic doses, deucravacitinib does
not inhibit JAK1, JAK2 or JAK3.
Deucravacitinib is being studied in multiple immune-mediated
diseases, including psoriasis, psoriatic arthritis, lupus and
inflammatory bowel disease. In addition to POETYK PSO-1 and POETYK
PSO-2, Bristol Myers Squibb is evaluating deucravacitinib in three
other Phase 3 studies in psoriasis: POETYK PSO-3 (NCT04167462);
POETYK PSO-4 (NCT03924427); POETYK PSO-LTE (NCT04036435).
Deucravacitinib is not approved for use in any country.
About the Phase 3 POETYK PSO-1 and POETYK PSO-2
Studies
PrOgram to Evaluate the efficacy and safety
of deucravacitinib, a selective TYK2 inhibitor (POETYK)
PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) are global Phase
3 studies designed to evaluate the safety and efficacy of
deucravacitinib compared to placebo and Otezla® (apremilast) in
patients with moderate to severe plaque psoriasis. Both POETYK
PSO-1, which enrolled 666 patients, and POETYK PSO-2, which
enrolled 1,020 patients, were multi-center, randomized,
double-blind trials that evaluated deucravacitinib (6 mg once
daily) compared with placebo and Otezla (30 mg twice daily). POETYK
PSO-2 included a randomized withdrawal and retreatment period after
Week 24.
The co-primary endpoints of both POETYK PSO-1 and POETYK PSO-2
were the percentage of patients who achieved Psoriasis Area and
Severity Index (PASI) 75 response and those who achieved static
Physician's Global Assessment (sPGA) score of 0 or 1 at Week 16
versus placebo. Key secondary endpoints of the trials included the
percentage of patients who achieved PASI 75 and sPGA 0/1 compared
to Otezla at Week 16 and other measures evaluating deucravacitinib
versus placebo and Otezla.
About Psoriasis
Psoriasis is a widely prevalent, chronic, systemic
immune-mediated disease that substantially impairs patients’
physical health, quality of life and work productivity. Psoriasis
is a serious global problem, with at least 100 million people
worldwide impacted by some form of the disease, including around 14
million people in Europe and approximately 7.5 million people in
the United States. Nearly one-quarter of people with psoriasis have
cases that are considered moderate to severe. Up to 90 percent of
patients with psoriasis have psoriasis vulgaris, or plaque
psoriasis, which is characterized by distinct round or oval plaques
typically covered by silvery-white scales. Despite the availability
of effective systemic therapy, many patients with moderate to
severe psoriasis remain undertreated or even untreated and are
dissatisfied with current treatments. People with psoriasis report
an impact on their emotional well-being, straining both personal
and professional relationships and causing a reduced quality of
life. Psoriasis is associated with multiple comorbidities that may
impact patients’ well-being, including psoriatic arthritis,
cardiovascular disease, metabolic syndrome, obesity, diabetes,
inflammatory bowel disease and depression.
Bristol Myers Squibb: Pioneering Paths Forward in Immunology
to Transform Patients’ Lives
Bristol Myers Squibb is inspired by a single vision –
transforming patients’ lives through science. For people living
with immune-mediated diseases, the debilitating reality of enduring
chronic symptoms and disease progression can take a toll on their
physical, emotional and social well-being, making simple tasks and
daily life a challenge. Driven by our deep understanding of the
immune system that spans over 20 years of experience, and our
passion to help patients, the company continues to pursue
pathbreaking science with the goal of delivering meaningful
solutions that address unmet needs in rheumatology,
gastroenterology, dermatology and multiple sclerosis. We follow the
science, aiming to tailor therapies to individual needs, improve
outcomes and expand treatment options by working to identify
mechanisms with the potential to achieve long-term remission – and
perhaps even cures – in the future. By building partnerships with
researchers, patients and caregivers to deliver innovative
treatments, Bristol Myers Squibb strives to elevate patient care to
new standards and deliver what matters most – the promise of living
a better life.
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.
Celgene and Juno Therapeutics are wholly owned subsidiaries of
Bristol-Myers Squibb Company. In certain countries outside the
U.S., due to local laws, Celgene and Juno Therapeutics are referred
to as, Celgene, a Bristol Myers Squibb company and Juno
Therapeutics, a Bristol Myers Squibb company.
Otezla® (apremilast) is a registered trademark of Amgen Inc.
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 that the NDA may not be accepted for
filing by the FDA without the provision of further information or
responses to additional requests, that deucravacitinib (BMS-986165)
may not receive regulatory approval for the indication described in
this release in the currently anticipated timeline or at all, any
marketing approvals, if granted, may have significant limitations
on their use, and, if approved, whether such product candidate for
such 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, 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, 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.
corporatefinancial-news
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211129005192/en/
Bristol Myers Squibb
Media Inquiries: media@bms.com
Investors: Tim Power 609-252-7509
Timothy.Power@bms.com
Nina Goworek 908-673-9711 Nina.Goworek@bms.com
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Feb 2024 to Mar 2024
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Mar 2023 to Mar 2024