- Patients achieving a high level of facial
repigmentation (≥F-VASI90) at Week 52 maintained durable response
one year following withdrawal of treatment
- Continued treatment with Opzelura for up to
two years resulted in sustained facial repigmentation and further
improvements in facial and total body repigmentation
- Data featured as oral presentations in two
late-breaking abstract sessions at the 2023 American Academy of
Dermatology (AAD) Annual Meeting
Incyte (Nasdaq:INCY) today announced new 104-week results from
the pivotal Phase 3 TRuE-V clinical trial program evaluating
Opzelura® (ruxolitinib) cream 1.5% in patients 12 years of
age and older with nonsegmental vitiligo, a chronic autoimmune
disease characterized by depigmentation of skin. These data were
presented today in two late-breaking oral presentations (Session:
S025 – Late Breaking Research: Session 1) at the 2023 American
Academy of Dermatology (AAD) Annual Meeting, held from March 17-21
in New Orleans.
The 104-week long-term extension (LTE) data build on the
positive 52-week TRuE-V1 and TRuE-V2 results previously announced
and published in The New England Journal of Medicine.
“The results presented today at AAD are significant because they
provide important long-term efficacy and safety data for
nonsegmental vitiligo patients treated with Opzelura,” said Jim
Lee, M.D., Ph.D., Group Vice President, Inflammation &
Autoimmunity, Incyte. “The data, which showed improvements in both
facial and total body repigmentation with continued treatment,
further our understanding of the long-term benefits of Opzelura as
a safe and meaningful pharmacologic treatment option for vitiligo
patients.”
The LTE evaluated TRuE-V1 and TRuE-V2 study participants from
Weeks 52 to 104 in two separate cohorts based on patients who
achieved a complete or almost complete response by Week 52. In the
cohort of patients who achieved complete or almost complete facial
repigmentation (≥F-VASI90, Cohort A), patients were randomized in a
double-blind fashion to receive Opzelura twice daily (BID) or
vehicle (i.e., Opzelura withdrawal) through Week 104 to evaluate
time to relapse (defined as <F-VASI75) and time to maintain
≥F-VASI90 response; time to regain F-VASI75 and F-VASI90 response
after relapse (with reinitiation of Opzelura treatment) was also
evaluated. In the cohort of patients who did not achieve complete
or almost complete facial repigmentation (<F-VASI90, Cohort B),
all patients were continued on Opzelura BID to evaluate long-term
efficacy and safety.
Key findings from Cohort A:
- Many patients who achieved a high level of facial
repigmentation (≥F-VASI90) in TRuE-V1/TRuE-V2 were able to maintain
durable response for one year after discontinuing Opzelura
treatment.
- Approximately 29% of patients randomized to the withdrawal arm
(i.e., applying vehicle cream) relapsed (<F-VASI75) during the
extension period (through Week 104).
- Among patients who relapsed (<F-VASI75) in the withdrawal
arm, 75% of patients regained ≥F-VASI75 once treatment with
Opzelura was reinitiated (median 12 weeks) and 69% of patients
regained ≥F-VASI90.
- For those continuing Opzelura treatment, approximately 62% of
patients who achieved ≥F-VASI90 at Week 52 maintained response for
one year with ongoing Opzelura treatment.
- Opzelura was well tolerated with no serious treatment-related
adverse events through Week 104. Mild or moderate treatment-related
adverse events among patients in the Opzelura arm included
application site dermatitis, application site rash and
hyperlipidemia.
Key findings from Cohort B:
- In patients who did not achieve near complete facial
repigmentation (<F-VASI90) at Week 52 and continued treatment
with Opzelura, improvements in facial and total body
repigmentation, as shown by greater proportions of patients
reaching F-VASI75 and T-VASI50, were observed through Week 104.
- For patients treated with Opzelura from Day 1 in the parent
studies (TRuE-V1 and TRuE-V2), the percentage who achieved F-VASI75
at Week 104 more than doubled (66%) compared to Week 52 (31%), and
approximately 34% attained F-VASI90 at Week 104.
- Additionally, T-VASI50 was achieved at Week 104 by 64% of
TRuE-V1 and TRuE-V2 patients applying Opzelura since Day 1,
increasing from 43% at Week 52.
- Opzelura was well tolerated with no serious treatment-related
adverse events through Week 104. All treatment–related adverse
events in the Opzelura arm were mild or moderate, the most common
being application site pruritus.
“I am extremely encouraged by these data, which show continued
improvements in facial and total body repigmentation over two years
of treatment with Opzelura,” said David Rosmarin, M.D., Chair,
Department of Dermatology at Indiana University School of Medicine.
“Vitiligo is a chronic condition and these results demonstrate the
long-term potential of this medical treatment for people with
vitiligo who are interested in repigmentation.”
About Vitiligo
Vitiligo is a chronic autoimmune disease characterized by
depigmentation of skin that results from the loss of
pigment-producing cells known as melanocytes. Overactivity 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 vitiligo1. The
overall prevalence of the condition is estimated to be
approximately 2-3 million2, with the majority of patients
(approximately 85%) suffering from nonsegmental vitiligo3. Vitiligo
can occur at any age, although many patients with vitiligo will
experience initial onset before the age of 304.
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 Opzelura 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, 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.
On February 24, 2023, Incyte announced that the European
Medicines Agency (EMA) Committee for Medicinal Products for Human
Use (CHMP) issued a positive opinion recommending the approval of
ruxolitinib cream for the treatment of non-segmental vitiligo with
facial involvement in adults and adolescents from 12 years of age.
The marketing authorization application (MAA) and CHMP opinion are
now under review by the European Commission, which has the
authority to grant centralized marketing authorizations for
medicinal products in the EU.
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. Today, we are building on
this legacy as we discover and develop innovative dermatology
treatments to bring solutions to patients in need.
Our research and development efforts in dermatology are
initially focused on leveraging our knowledge of the JAK-STAT
pathway. We are exploring the potential of JAK inhibition for a
number of immune-mediated dermatologic conditions with a high unmet
medical need, including atopic dermatitis, vitiligo, hidradenitis
suppurativa, lichen planus, lichen sclerosus and prurigo
nodularis.
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 the presentation of data from Incyte’s clinical trial
programs and the long-term potential of Opzelura as a treatment for
vitiligo, 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 and the ability to enroll subjects in accordance with
planned schedules; the effects of the COVID-19 pandemic and
measures to address the pandemic on the Company’s clinical trials,
supply chain, and other third-party providers and development and
discovery operations; determinations made by the FDA and other
regulatory authorities; the Company’s dependence on its
relationships with its collaboration partners; the efficacy or
safety of the Company’s products and the products of the Company’s
collaboration partners; the acceptance of the Company’s products
and the products of the Company’s collaboration partners 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 U.S. Securities and
Exchange Commission, including its annual report for the year
ending December 31, 2022. The Company disclaims any intent or
obligation to update these forward-looking statements.
_______________________ 1 Bergqvist C, Ezzedine K. Vitiligo: A
Review. Dermatology. 2020;236:571-592. 2 Gandhi K, et al.
Prevalence of vitiligo among adults in the United States. JAMA
Dermatol. 2022;158(1):43-50. 3 Ezzedine K, et al. Seminar:
Vitiligo. Lancet. 2015;386:74–84. 4 Frisoli M, et al. Vitiligo:
mechanisms of pathogenesis and treatment. Annu. Rev. Immunol.
2020;38(1):621-648.
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version on businesswire.com: https://www.businesswire.com/news/home/20230318005040/en/
Media Erica Cech +1 302 274 4324 ecech@incyte.com
Catalina Loveman +1 302 498 6171 cloveman@incyte.com
Investors Christine Chiou cchiou@incyte.com
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