Incyte (Nasdaq:INCY) today announced that multiple abstracts
featuring data from its dermatology portfolio will be presented at
the upcoming 2022 European Academy of Dermatology and Venereology
(EADV) Congress, held September 7-10, 2022, in Milan and
virtually.
“We are excited for the opportunity to present research from our
growing dermatology portfolio at this year’s EADV Congress,
including data on ruxolitinib cream in vitiligo, on the heels of
our recent U.S. Food and Drug Administration (FDA) approval in this
indication,” said Jim Lee, M.D., Ph.D., Group Vice President,
Inflammation & Autoimmunity, Incyte. “We additionally look
forward to several presentations of data on our oral JAK1
inhibitor, povorcitinib (formerly INCB054707), which we are
advancing into Phase 3 development for hidradenitis
suppurativa.”
Key abstracts include:
Oral Presentation
Vitiligo
Efficacy and Safety of Ruxolitinib Cream for the treatment of
Vitiligo: Week 52 Pooled Analysis of the TRuE-V Phase 3 Studies
(Abstract #FC01.04. Session: Free Communications in Miscellaneous.
Thursday, September 8, 3:00 a.m. EST)
Poster Presentations
Vitiligo
Efficacy and Safety of Ruxolitinib Cream for the Treatment of
Vitiligo by Patient Demographics and Baseline Clinical
Characteristics: Week 52 Pooled Subgroup Analysis from Two
Randomized Phase 3 Studies (Abstract #P1383. Session:
Pigmentary Disorders)
Mental Health and Psychosocial Burden Among Patients Living
with Vitiligo In Europe: Findings from the Global VALIANT Study
(Abstract #P1384. Session: Pigmentary Disorders)
Exploring the Natural and Treatment History of Vitiligo in
Europe: Findings from the Global VALIANT Study (Abstract
#P1401. Session: Pigmentary Disorders)
Treatment Burden Among Patients with Vitiligo: Findings from
the Global VALIANT Study (Abstract #P1402. Session: Pigmentary
Disorders)
Quality of Life and Disease Severity in Patients with
Vitiligo: Findings from the Global VALIANT Study (Abstract
#P1403. Session: Pigmentary Disorders)
Atopic Dermatitis
Ruxolitinib Cream Provided Progressive Improvement in
Patients with Atopic Dermatitis who did not Achieve Investigator’s
Global Assessment Treatment Success at Week 8: Pooled Results from
Two Phase 3 Studies (Abstract #P0247. Session: Atopic
Dermatitis/Eczema)
Efficacy of Ruxolitinib Cream for the Treatment of Atopic
Dermatitis by Anatomic Region: Pooled Analysis from Two Randomized
Phase 3 Studies (Abstract #P0248. Session: Atopic
Dermatitis/Eczema)
Hidradenitis Suppurativa
Efficacy and Safety of the Janus Kinase (JAK) 1 Inhibitor
INCB054707 in Patients (Pts) with Hidradenitis Suppurativa (HS):
Results from a Randomized, Placebo-Controlled, Phase 2 Dose-Ranging
Study (Abstract #P0004. Session: Acne and Related Disorders,
Hidradenitis Suppurativa)
Effects of the Janus Kinase (JAK) 1 Inhibitor INCB054707 on
Patient (Pt)-Reported Quality of Life (QoL) in Hidradenitis
Suppurativa (HS): Results from a Randomized, Placebo-Controlled,
Phase 2 Dose-Ranging Study (Abstract #P0005. Session: Acne and
Related Disorders, Hidradenitis Suppurativa)
Effects of the Janus Kinase (JAK) 1 Inhibitor INCB054707 on
Patient (Pt)-Reported Skin Pain, Analgesic Use, and Itch in
Hidradenitis Suppurativa (HS): Results from a Randomized,
Placebo-Controlled, Phase 2 Dose-Ranging Study (Abstract
#P0006. Session: Acne and Related Disorders, Hidradenitis
Suppurativa)
More information regarding the congress is available on the EADV
website: https://eadvcongress2022.org/. Congress content will be
available on the EADV Virtual platform for a period of three months
following the congress.
About Povorcitinib (INCB054707) Povorcitinib (INCB054707)
is an oral small-molecule JAK1 inhibitor currently in Phase 2
clinical trials for hidradenitis suppurativa (HS), vitiligo and
prurigo nodularis. A Phase 3 study in HS is expected to begin by
end of 2022.
About Opzelura™ (ruxolitinib) Cream 1.5% Opzelura, a
novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor
ruxolitinib approved by the U.S. Food & Drug Administration for
the topical treatment of nonsegmental vitiligo in patients 12 years
of age and older, is the first and only treatment for
repigmentation approved for use in the United States. Opzelura is
also approved in the U.S. for the topical short-term and
non-continuous chronic treatment of mild to moderate atopic
dermatitis (AD) in non-immunocompromised patients 12 years of age
and older whose disease is not adequately controlled with topical
prescription therapies, or when those therapies are not advisable.
Use of Opzelura in combination with therapeutic biologics, other
JAK inhibitors, or potent immunosuppressants, such as azathioprine
or cyclosporine, is not recommended.
The marketing authorization application (MAA) for ruxolitinib
cream as a potential treatment for adolescents and adults (age
>12 years) with nonsegmental vitiligo with facial involvement is
under review at the European Medicines Agency (EMA).
Incyte has worldwide rights for the development and
commercialization of ruxolitinib cream, marketed in the United
States as Opzelura. In April 2022, Incyte entered into a strategic
alliance agreement with Maruho Co., Ltd. for the development,
manufacturing and exclusive commercialization of ruxolitinib cream
for treatment of autoimmune and inflammatory dermatology
indications in Japan.
Opzelura is a trademark of Incyte.
IMPORTANT SAFETY INFORMATION
OPZELURA is for use on the skin only. Do not use OPZELURA in
your eyes, mouth, or vagina.
OPZELURA may cause serious side effects, including:
Serious Infections: OPZELURA contains ruxolitinib.
Ruxolitinib belongs to a class of medicines called Janus kinase
(JAK) inhibitors. JAK inhibitors are medicines that affect your
immune system. JAK inhibitors can lower the ability of your immune
system to fight infections. Some people have had serious infections
while taking JAK inhibitors by mouth, including tuberculosis (TB),
and infections caused by bacteria, fungi, or viruses that can
spread throughout the body. Some people have been hospitalized or
died from these infections. Some people have had serious infections
of their lungs while taking OPZELURA. Your healthcare provider
should watch you closely for signs and symptoms of TB during
treatment with OPZELURA.
OPZELURA should not be used in people with an active, serious
infection, including localized infections. You should not start
using OPZELURA if you have any kind of infection unless your
healthcare provider tells you it is okay. You may be at a higher
risk of developing shingles (herpes zoster) while using
OPZELURA.
Increased risk of death due to any reason (all causes):
Increased risk of death has happened in people 50 years of age and
older who have at least 1 heart disease (cardiovascular) risk
factor and are taking a medicine in the class of medicines called
JAK inhibitors by mouth.
Cancer and immune system problems: OPZELURA may increase
your risk of certain cancers by changing the way your immune system
works. Lymphoma and other cancers have happened in people taking a
medicine in the class of medicines called JAK inhibitors by mouth.
People taking JAK inhibitors by mouth have a higher risk of certain
cancers including lymphoma and lung cancer, especially if they are
a current or past smoker. Some people have had skin cancers while
using OPZELURA. Your healthcare provider will regularly check your
skin during your treatment with OPZELURA. Limit the amount of time
you spend in the sunlight. Wear protective clothing when you are in
the sun and use a broad-spectrum sunscreen.
Increased risk of major cardiovascular events: Increased
risk of major cardiovascular events such as heart attack, stroke,
or death have happened in people 50 years of age and older who have
at least 1 heart disease (cardiovascular) risk factor and taking a
medicine in the class of medicines called JAK inhibitors by mouth,
especially in current or past smokers.
Blood clots: Blood clots in the veins of your legs (deep
vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen
in some people taking OPZELURA. This may be life-threatening. Blood
clots in the vein of the legs (deep vein thrombosis, DVT) and lungs
(pulmonary embolism, PE) have happened more often in people who are
50 years of age and older and with at least 1 heart disease
(cardiovascular) risk factor taking a medicine in the class of
medicines called JAK inhibitors by mouth.
Low blood cell counts: OPZELURA may cause low platelet
counts (thrombocytopenia), low red blood cell counts (anemia), and
low white blood cell counts (neutropenia). If needed, your
healthcare provider will do a blood test to check your blood cell
counts during your treatment with OPZELURA and may stop your
treatment if signs or symptoms of low blood cell counts happen.
Cholesterol increases: Cholesterol increase has happened
in people when ruxolitinib is taken by mouth. Tell your healthcare
provider if you have high cholesterol or triglycerides.
Before starting OPZELURA, tell your healthcare provider if
you:
- have an infection, are being treated for one, or have had an
infection that does not go away or keeps coming back
- have diabetes, chronic lung disease, HIV, or a weak immune
system
- have TB or have been in close contact with someone with TB
- have had shingles (herpes zoster)
- have or have had hepatitis B or C
- live, have lived in, or have traveled to certain parts of the
country (such as the Ohio and Mississippi River valleys and the
Southwest) where there is an increased chance for getting certain
kinds of fungal infections. These infections may happen or become
more severe if you use OPZELURA. Ask your healthcare provider if
you do not know if you have lived in an area where these infections
are common.
- think you have an infection or have symptoms of an infection
such as: fever, sweating, or chills, muscle aches, cough or
shortness of breath, blood in your phlegm, weight loss, warm, red,
or painful skin or sores on your body, diarrhea or stomach pain,
burning when you urinate or urinating more often than usual,
feeling very tired
- have ever had any type of cancer, or are a current or past
smoker
- have had a heart attack, other heart problems, or a stroke
- have had blood clots in the veins of your legs or lungs in the
past
- have high cholesterol or triglycerides
- have or have had low white or red blood cell counts
- are pregnant or plan to become pregnant. It is not known if
OPZELURA will harm your unborn baby. There is a pregnancy exposure
registry for individuals who use OPZELURA during pregnancy. The
purpose of this registry is to collect information about the health
of you and your baby. If you become exposed to OPZELURA during
pregnancy, you and your healthcare provider should report exposure
to Incyte Corporation at 1-855-463-3463.
- are breastfeeding or plan to breastfeed. It is not known if
OPZELURA passes into your breast milk. Do not breastfeed during
treatment with OPZELURA and for about 4 weeks after the last
dose.
After starting OPZELURA:
- Call your healthcare provider right away if you have any
symptoms of an infection. OPZELURA can make you more likely to get
infections or make worse any infections that you have.
- Get emergency help right away if you have any symptoms of a
heart attack or stroke while using OPZELURA, including:
- discomfort in the center of your chest that lasts for more than
a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest,
throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or
stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- Tell your healthcare provider right away if you have any signs
and symptoms of blood clots during treatment with OPZELURA,
including: swelling, pain, or tenderness in one or both legs,
sudden, unexplained chest or upper back pain, or shortness of
breath or difficulty breathing.
- Tell your healthcare provider right away if you develop or have
worsening of any symptoms of low blood cell counts, such as:
unusual bleeding, bruising, tiredness, shortness of breath, or
fever.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
The most common side effects of OPZELURA in people treated
for atopic dermatitis include: common cold (nasopharyngitis),
diarrhea, bronchitis, ear infection, increase in a type of white
blood cell (eosinophil) count, hives, inflamed hair pores
(folliculitis), swelling of the tonsils (tonsillitis), and runny
nose (rhinorrhea).
The most common side effects of OPZELURA in people treated
for nonsegmental vitiligo include: acne at the application
site, itching at the application site, common cold
(nasopharyngitis), headache, urinary tract infection, redness at
the application site, and fever.
These are not all of the possible side effects of OPZELURA. Call
your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-FDA-1088. You may also report side
effects to Incyte Corporation at 1-855-463-3463.
Please see the Full Prescribing Information,
including Boxed Warning, and Medication Guide for
OPZELURA.
INDICATIONS AND USAGE
OPZELURA is a prescription medicine used on the skin (topical)
for:
- short-term and non-continuous chronic treatment of mild to
moderate eczema (atopic dermatitis) in non-immunocompromised adults
and children 12 years of age and older whose disease is not well
controlled with topical prescription therapies or when those
therapies are not recommended
- the treatment of a type of vitiligo called nonsegmental
vitiligo in adults and children 12 years of age and older
The use of OPZELURA along with therapeutic biologics, other JAK
inhibitors, or strong immunosuppressants such as azathioprine or
cyclosporine is not recommended.
It is not known if OPZELURA is safe and effective in children
less than 12 years of age with atopic dermatitis or nonsegmental
vitiligo.
About Incyte Dermatology
Incyte’s science-first approach and expertise in immunology has
formed the foundation of the company. In Dermatology, the Company’s
research and development efforts are focused on leveraging our
knowledge of the JAK-STAT pathway to identify and develop topical
and oral therapies with the potential to modulate immune pathways
driving uncontrolled inflammation and help restore normal immune
function.
Currently, Incyte is exploring the potential of JAK inhibition
for additional immune-mediated dermatologic conditions with a high
unmet medical need, including hidradenitis suppurativa. To learn
more, visit the Dermatology section of Incyte.com.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical
company focused on finding solutions for serious unmet medical
needs through the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte,
please visit Incyte.com and follow @Incyte.
Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding Incyte’s dermatology portfolio; its plans to present data
from this portfolio at EADV; whether or when any development
compounds or combinations from that portfolio will be approved or
commercially available for use in humans (beyond the specific
geographic regions and indications for which Opzelura already has
been approved); and whether and when Opzelura and/or any of the
other compounds in Incyte’s clinical development pipeline, if
approved, might provide a successful treatment option for patients
with atopic dermatitis, vitiligo or other additional
immune-mediated dermatologic conditions with a high unmet medical
need contain predictions, estimates and other forward-looking
statements.
These forward-looking statements are based on Incyte’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments in and risks related to: unanticipated delays; further
research and development and the results of clinical trials
possibly being unsuccessful or insufficient to meet applicable
regulatory standards or warrant continued development; the ability
to enroll sufficient numbers of subjects in clinical trials; the
effects of the COVID-19 pandemic and measures to address the
pandemic on Incyte’s clinical trials, supply chain, other
third-party providers and development and discovery operations;
determinations made by the U.S. FDA and other regulatory
authorities outside of the United States; the efficacy or safety of
Incyte’s products; the acceptance of Incyte’s products in the
marketplace; market competition; sales, marketing, manufacturing
and distribution requirements; and other risks detailed from time
to time in Incyte’s reports filed with the Securities and Exchange
Commission, including its annual report and its quarterly report on
Form 10-Q for the quarter ended June 30, 2022. Incyte disclaims any
intent or obligation to update these forward-looking
statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20220824005066/en/
Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
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