- Opzelura is the first and only FDA-approved product for
repigmentation in nonsegmental vitiligo
- Phase 3 data supporting the approval show treatment with
Opzelura resulted in improvements in facial and total body
repigmentation
- Fifty-two week data demonstrate continued improvements in
repigmentation with longer duration of treatment
- Investor conference call and webcast scheduled for July 19,
2022, at 8:00 a.m. EDT
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug
Administration (FDA) has approved Opzelura™ (ruxolitinib) cream
1.5% for the topical treatment of nonsegmental vitiligo in adult
and pediatric patients 12 years of age and older. Opzelura is the
first and only FDA-approved treatment for repigmentation in
patients with vitiligo, and the only topical formulation of a Janus
kinase (JAK) inhibitor approved in the United States. Vitiligo is a
chronic autoimmune disease characterized by depigmentation of
skin.
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Image of person with nonsegmental
vitiligo (Photo: Business Wire)
“With the approval of Opzelura in nonsegmental vitiligo, Incyte
has once again delivered a treatment to patients with high unmet
medical need who previously had no approved therapies,” said Hervé
Hoppenot, Chief Executive Officer, Incyte. “We are proud of
Incyte’s scientists and development teams that have made this
milestone possible, and we're pleased that eligible vitiligo
patients now have a choice to address repigmentation.”
In patients with non-segmental vitiligo, Opzelura is approved
for continuous topical use twice daily to affected areas of up to
10% body surface area. Satisfactory patient response may require
treatment with Opzelura for more than 24 weeks.
The FDA approval was based on data from the pivotal Phase 3
TRuE-V clinical trial program (TRuE-V1 and TRuE-V2), evaluating the
safety and efficacy of Opzelura versus vehicle in more than 600
people with nonsegmental vitiligo, age 12 and older. In the
studies, treatment with Opzelura resulted in significant
improvements in VASI scores, which represent improvements in facial
and total body repigmentation at Week 24 (primary analysis)
compared to vehicle (non-medicated cream) and in an open-label
extension at Week 52.
Results at Week 24, which were consistent across both studies,
showed that approximately 30% of patients treated with Opzelura
achieved ≥75% improvement from baseline in the facial Vitiligo Area
Scoring Index (F-VASI75), the primary endpoint, compared to
approximately 8% and 13% of patients treated with vehicle in
TRuE-V1 and TRuE-V2, respectively. At Week 52, approximately 50% of
Opzelura-treated patients achieved F-VASI75.
Additionally, at Week 24, more than 15% of patients treated with
Opzelura achieved ≥90% improvement from baseline in F-VASI
(F-VASI90), compared to approximately 2% of patients treated with
vehicle. At Week 52, the percentage of Opzelura-treated patients
who achieved F-VASI90 doubled to approximately 30%.
In the vehicle controlled period of the Phase 3 studies, the
most common adverse reactions (incidence ≥ 1%) are application site
acne, application site pruritus, nasopharyngitis, headache, urinary
tract infection, application site erythema, and pyrexia1. The
labeling for Opzelura includes a Boxed Warning for serious
infections, mortality, malignancy, major adverse cardiovascular
events and thrombosis. See additional Important Safety Information
below.
Week 52 data from the Phase 3 TRuE-V studies were featured in an
oral presentation at the late-breaking abstract session at the
American Academy of Dermatology (AAD) Annual 2022 Meeting.
Vitiligo is a chronic autoimmune disease characterized by
depigmentation of skin that results from the loss of
pigment-producing cells known as melanocytes. Over-activity of the
JAK signaling pathway is believed to drive inflammation involved in
the pathogenesis and progression of vitiligo. In the United States,
more than 1.5 million people are diagnosed with vitiligo2. The
overall prevalence of the condition is estimated to be
approximately 2-3 million3, with the majority of patients
(approximately 85%) suffering from nonsegmental vitiligo4. Vitiligo
can occur at any age, although many patients with vitiligo will
experience initial symptoms before the age of 305.
“Vitiligo is an immune-mediated disease that can be
unpredictable, making it particularly difficult to treat,” said
David Rosmarin, M.D., Vice Chair of Research and Education,
Department of Dermatology at Tufts Medical Center. “There have been
no FDA-approved therapies available to date and the approval of
Opzelura therefore marks a significant milestone. I welcome a
medical treatment that helps my patients with nonsegmental vitiligo
who are interested in potentially reversing the depigmentation
caused by their disease.”
In September 2021, Opzelura was approved by the FDA 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.
Incyte is committed to supporting patients and removing barriers
to access medicines. Eligible patients in the United States who are
prescribed Opzelura have access to IncyteCARES (Connecting to
Access, Reimbursement, Education and Support), a program offering
patient support, including financial assistance and ongoing
education and resources to eligible patients. For more information
about IncyteCARES, please visit www.incytecares.com or call
1-800-583-6964, Monday through Friday, from 8 a.m. to 8 p.m.
EDT.
Conference Call Information
Incyte will host an analyst and investor conference call and
webcast on July 19, 2022 at 8:00 a.m. EDT. The live and archived
webcast will be available via Investor.incyte.com.
To access the conference call, please dial 877-407-3042 for
domestic callers or 201-389-0864 for international callers. When
prompted, provide the conference identification number,
13730931.
If you are unable to participate, a replay of the conference
call will be available for 30 days. The replay dial-in number for
the United States is 877-660-6853 and the dial-in number for
international callers is 201-612-7415. To access the replay you
will need the conference identification number, 13730931.
The live webcast with slides can be accessed at
Investor.Incyte.com and will be available for replay for ninety
days.
About TRuE-V
The TRuE-V clinical trial program includes two Phase 3 studies,
TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573), evaluating the
safety and efficacy of ruxolitinib cream in patients with vitiligo.
Each study enrolled approximately 300 patients (age ≥12 years) who
have been diagnosed with nonsegmental vitiligo.
About Opzelura™ (ruxolitinib) Cream 1.5%
Opzelura, a novel cream formulation of Incyte’s selective
JAK1/JAK2 inhibitor ruxolitinib, is the first and only topical JAK
inhibitor approved for use in the United States, indicated for the
topical treatment of nonsegmental vitiligo in adult and pediatric
patients 12 years of age and older and 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.
In October 2021, Incyte announced the validation of the European
Marketing Authorization Application (MAA) for ruxolitinib cream as
a potential treatment for adolescents and adults (age >12 years)
with nonsegmental vitiligo with facial involvement.
Incyte has worldwide rights for the development and
commercialization of ruxolitinib cream, marketed in the United
States as Opzelura.
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 whether and when Opzelura might provide a successful
treatment option for patients with vitiligo, Incyte’s TRuE-V
clinical program and Incyte’s Dermatology program generally,
contain predictions, estimates and other forward-looking
statements.
These forward-looking statements are based on the Company’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 the Company’s clinical trials, supply
chain, other third-party providers and development and discovery
operations; determinations made by the FDA and other regulatory
authorities; the efficacy or safety of the Company’s products; the
acceptance of the Company’s products in the marketplace; market
competition; sales, marketing, manufacturing and distribution
requirements; and other risks detailed from time to time in the
Company’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 March 31, 2022. The Company
disclaims any intent or obligation to update these forward-looking
statements.
1
Opzelura Prescribing Information.
Wilmington, DE. Incyte Corporation.
2
Bergqvist C, Ezzedine K. Vitiligo: A
Review. Dermatology 2020;236:571-592.
3
Gandhi K, et al. Prevalence of vitiligo
among adults in the United States. JAMA Dermatol.
2022;158(1):43-50.
4
Ezzedine K, et al. Seminar: Vitiligo.
Lancet 2015;386:74–84.
5
Frisoli M, et al. Vitiligo: mechanisms of
pathogenesis and treatment. Annu. Rev. Immunol.
2020;38(1):621-648.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220718005819/en/
Media Jenifer Antonacci 302-498-7036
jantonacci@incyte.com
Erica Cech 302-274-4324 ecech@incyte.com
Investors Christine Chiou 302-274-4773
cchiou@incyte.com
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