CHMP recommendation based on positive
results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials and
an additional two years of data from the POETYK PSO long-term
extension trial
Sotyktu has demonstrated superior efficacy
over twice-daily Otezla® (apremilast) and placebo in improving skin
clearance and symptoms
If approved, Sotyktu would be the first
oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor in
the European Union for the treatment of any disease
Bristol Myers Squibb (NYSE: BMY) today announced that the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency has recommended the approval of Sotyktu
(deucravacitinib) for the treatment of adults with
moderate-to-severe plaque psoriasis. Sotyktu, an oral medication
taken once-daily, is a first-in-class, selective, allosteric
tyrosine kinase 2 (TYK2) inhibitor for the treatment of
moderate-to-severe plaque psoriasis in adults who are candidates
for systemic therapy. The CHMP recommendation will now be reviewed
by the European Commission, which has the authority to approve
medicines for the European Union (EU).
“Patients living with moderate-to-severe psoriasis still
experience debilitating symptoms and many remain untreated,
undertreated or dissatisfied with current options, with a
significant need for more effective and well-tolerated oral
therapies,” said Samit Hirawat, MD, chief medical officer, Bristol
Myers Squibb. “Today’s positive CHMP opinion is an important
advancement for patients in the EU to address the unmet needs they
face, and we’re proud to be one step closer to bringing this
first-in-class medicine with demonstrated durable efficacy to
patients in need. We look forward to potentially seeing Sotyktu
become the oral standard of care.”
The CHMP adopted this positive opinion based on results from the
pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 trials, which
evaluated once-daily Sotyktu in patients with moderate-to-severe
plaque psoriasis versus placebo and twice-daily Otezla®
(apremilast), as well as an additional two years of data from the
POETYK PSO long-term extension trial. Sotyktu demonstrated
significant and clinically meaningful improvements in skin
clearance, symptom burden and quality of life measures compared to
placebo and Otezla. Sotyktu was well-tolerated with a low rate of
discontinuation due to adverse events. The most common adverse
reactions (≥1% of patients on Sotyktu) included upper respiratory
infections, herpes simplex infections, oral ulcers, folliculitis
and acneiform rash. The results of the Phase 3 POETYK PSO-1 and
POETYK PSO-2 trials were published in the Journal of the American
Academy of Dermatology.
The U.S. Food and Drug Administration (FDA) approved Sotyktu for
the treatment of adults with moderate-to-severe plaque psoriasis
who are candidates for systemic therapy or phototherapy in
September 2022, and Japan's Ministry of Health, Labour and Welfare
approved Sotyktu for the treatment of adults with plaque psoriasis,
generalized pustular psoriasis, and erythrodermic psoriasis who
have had an inadequate response to conventional therapies in
September 2022. In addition to the European Medicines Agency,
Sotyktu is also under regulatory review by other health authorities
around the world for the treatment of moderate-to-severe plaque
psoriasis.
Bristol Myers Squibb thanks the patients and investigators
involved in the POETYK PSO clinical trial program.
About the POETYK PSO Clinical Trial Program
PrOgram to Evaluate the efficacy and safety
of Sotyktu (deucravacitinib), a selective TYK2 inhibitor
(POETYK) PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) were
global Phase 3 studies designed to evaluate the safety and efficacy
of Sotyktu 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 Sotyktu (6 mg once daily) compared to 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 (clear/almost
clear) 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 Sotyktu versus placebo and Otezla.
Following the 52-week POETYK PSO-1 and POETYK PSO-2 trials,
patients could enroll in the ongoing POETYK PSO long-term extension
(LTE) trial (NCT04036435) and receive open-label Sotyktu 6 mg
once-daily. 1,221 patients enrolled in the LTE trial and received
at least one dose of Sotyktu. Efficacy was analyzed utilizing
treatment failure rules (TFR) method of imputation, along with
sensitivity analyses using modified non-responder imputation and
as-observed analysis, which have been used in similar analyses with
other agents. In addition to POETYK PSO-1, POETYK PSO-2 and POETYK
PSO-LTE, Bristol Myers Squibb has evaluated Sotyktu in two other
Phase 3 studies in psoriasis: POETYK PSO-3 (NCT04167462) and POETYK
PSO-4 (NCT03924427).
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.
About Sotyktu (deucravacitinib)
Sotyktu (deucravacitinib) is an oral, selective, allosteric
tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of
action, representing a new class of small molecules. It is the
first selective TYK2 inhibitor in clinical studies across multiple
immune-mediated diseases. Bristol Myers Squibb scientists designed
Sotyktu to selectively target TYK2, thereby inhibiting signaling of
interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key
cytokines involved in the pathogenesis of multiple immune-mediated
diseases. Sotyktu achieves a high degree of selectivity by binding
to the regulatory domain of TYK2, resulting in allosteric
inhibition of TYK2 and its downstream functions. Sotyktu
selectively inhibits TYK2 at physiologically relevant
concentrations. At therapeutic doses, Sotyktu does not inhibit
JAK1, JAK2 or JAK3.
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 neurology. 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.
SOTYKTU U.S. INDICATION
SOTYKTU™ (deucravacitinib) is indicated for the treatment of
moderate-to-severe plaque psoriasis in adults who are candidates
for systemic therapy or phototherapy.
Limitations of Use:
SOTYKTU is not recommended for use in combination with other
potent immunosuppressants.
IMPORTANT SAFETY
INFORMATION
CONTRAINDICATIONS
SOTYKTU is contraindicated in patients with a history of
hypersensitivity reaction to deucravacitinib or to any of the
excipients in SOTYKTU.
WARNINGS AND PRECAUTIONS
Hypersensitivity: Hypersensitivity reactions such as
angioedema have been reported. If a clinically significant
hypersensitivity reaction occurs, institute appropriate therapy and
discontinue SOTYKTU.
Infections: SOTYKTU may increase the risk of infections.
Serious infections have been reported in patients with psoriasis
who received SOTYKTU. The most common serious infections reported
with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU
in patients with an active or serious infection. Consider the risks
and benefits of treatment prior to initiating SOTYKTU in
patients:
- with chronic or recurrent infection
- who have been exposed to tuberculosis
- with a history of a serious or an opportunistic infection
- with underlying conditions that may predispose them to
infection.
Closely monitor patients for the development of signs and
symptoms of infection during and after treatment. A patient who
develops a new infection during treatment should undergo prompt and
complete diagnostic testing, have appropriate antimicrobial therapy
initiated and be closely monitored. Interrupt SOTYKTU if a patient
develops a serious infection. Do not resume SOTYKTU until the
infection resolves or is adequately treated.
Viral Reactivation
Herpes virus reactivation (e.g., herpes zoster, herpes simplex)
was reported in clinical trials with SOTYKTU. Through Week 16,
herpes simplex infections were reported in 17 patients (6.8 per 100
patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100
patient-years) treated with placebo. Multidermatomal herpes zoster
was reported in an immunocompetent patient. During PSO-1, PSO-2,
and the open-label extension trial, the majority of patients who
reported events of herpes zoster while receiving SOTYKTU were under
50 years of age. The impact of SOTYKTU on chronic viral hepatitis
reactivation is unknown. Consider viral hepatitis screening and
monitoring for reactivation in accordance with clinical guidelines
before starting and during therapy with SOTYKTU. If signs of
reactivation occur, consult a hepatitis specialist. SOTYKTU is not
recommended for use in patients with active hepatitis B or
hepatitis C.
Tuberculosis (TB): In clinical trials, of 4 patients with
latent TB who were treated with SOTYKTU and received appropriate TB
prophylaxis, no patients developed active TB (during the mean
follow-up of 34 weeks). One patient, who did not have latent TB,
developed active TB after receiving 54 weeks of SOTYKTU. Evaluate
patients for latent and active TB infection prior to initiating
treatment with SOTYKTU. Do not administer SOTYKTU to patients with
active TB. Initiate treatment of latent TB prior to administering
SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in
patients with a past history of latent or active TB in whom an
adequate course of treatment cannot be confirmed. Monitor patients
for signs and symptoms of active TB during treatment.
Malignancy including Lymphomas: Malignancies, including
lymphomas, were observed in clinical trials with SOTYKTU. Consider
the benefits and risks for the individual patient prior to
initiating or continuing therapy with SOTYKTU, particularly in
patients with a known malignancy (other than a successfully treated
non-melanoma skin cancer) and patients who develop a malignancy
when on treatment with SOTYKTU.
Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU
was associated with an increased incidence of asymptomatic creatine
phosphokinase (CPK) elevation and rhabdomyolysis compared to
placebo.
Discontinue SOTYKTU if markedly elevated CPK levels occur or
myopathy is diagnosed or suspected. Instruct patients to promptly
report unexplained muscle pain, tenderness or weakness,
particularly if accompanied by malaise or fever.
Laboratory Abnormalities: Treatment with SOTYKTU was
associated with increases in triglyceride levels. Periodically
evaluate serum triglycerides according to clinical guidelines
during treatment. SOTYKTU treatment was associated with an increase
in the incidence of liver enzyme elevation compared to placebo.
Evaluate liver enzymes at baseline and thereafter in patients with
known or suspected liver disease according to routine management.
If treatment-related increases in liver enzymes occur and
drug-induced liver injury is suspected, interrupt SOTYKTU until a
diagnosis of liver injury is excluded.
Immunizations: Prior to initiating therapy with SOTYKTU,
consider completion of all age-appropriate immunizations according
to current immunization guidelines including prophylactic herpes
zoster vaccination. Avoid use of live vaccines in patients treated
with SOTYKTU. The response to live or non-live vaccines has not
been evaluated.
Potential Risks Related to JAK Inhibition: It is not
known whether tyrosine kinase 2 (TYK2) inhibition may be associated
with the observed or potential adverse reactions of Janus Kinase
(JAK) inhibition. In a large, randomized, postmarketing safety
trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50
years of age and older with at least one cardiovascular risk
factor, higher rates of all-cause mortality, including sudden
cardiovascular death, major adverse cardiovascular events, overall
thrombosis, deep venous thrombosis, pulmonary embolism, and
malignancies (excluding non-melanoma skin cancer) were observed in
patients treated with the JAK inhibitor compared to those treated
with TNF blockers. SOTYKTU is not approved for use in RA.
ADVERSE REACTIONS
Most common adverse reactions (≥1% of patients on SOTYKTU and
more frequently than with placebo) include upper respiratory
infections, blood creatine phosphokinase increased, herpes simplex,
mouth ulcers, folliculitis and acne.
SPECIFIC POPULATIONS
Pregnancy: Available data from case reports on SOTYKTU
use during pregnancy are insufficient to evaluate a drug-associated
risk of major birth defects, miscarriage, or adverse maternal or
fetal outcomes. Report pregnancies to the Bristol-Myers Squibb
Company’s Adverse Event reporting line at 1-800-721-5072.
Lactation: There are no data on the presence of SOTYKTU
in human milk, the effects on the breastfed infant, or the effects
on milk production. SOTYKTU is present in rat milk. When a drug is
present in animal milk, it is likely that the drug will be present
in human milk. The developmental and health benefits of
breastfeeding should be considered along with the mother’s clinical
need for SOTYKTU and any potential adverse effects on the breastfed
infant from SOTYKTU or from the underlying maternal condition.
Hepatic Impairment: SOTYKTU is not recommended for use in
patients with severe hepatic impairment.
SOTYKTU is available in 6 mg tablets.
Please see U.S. Full Prescribing Information,
including Medication Guide, for SOTYKTU.
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.
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 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, that the CHMP opinion is not binding on the European
Commission, that SotyktuTM (deucravacitinib) may not receive
regulatory approval for the indication described in this release in
the currently anticipated timeline or at all, that any marketing
approvals, if granted, may have significant limitations on their
use, and, if approved, whether such product candidate for the
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, 2021, 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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