- Use of ruxolitinib cream (Opzelura™) resulted
in further improvement in facial and total body repigmentation at
Week 52
- Results will be featured as an oral
presentation in a late-breaking abstract session at the 2022
American Academy of Dermatology (AAD) Annual Meeting
Incyte (Nasdaq:INCY) today announced new 52-week results from
its pivotal Phase 3 TRuE-V clinical trial program evaluating
ruxolitinib cream (Opzelura™), a topical JAK1/JAK2 inhibitor, in
adolescent and adult patients (age ≥12 years) with nonsegmental
vitiligo. These data were presented today as an oral presentation
in a late-breaking abstract session (Session #S026 – Late-Breaking
Research: Clinical Trials) at the 2022 American Academy of
Dermatology (AAD) Annual Meeting, held from March 25-29 in
Boston.
The 52-week results build on the previously announced positive
24-week results and include data from the 24-week double-blind and
28-week treatment extension periods of the Phase 3 TRuE-V1 and
TRuE-V2 studies. Findings from the Week 52 analysis showed that
patients applying 1.5% ruxolitinib cream twice daily (BID) had
clinically meaningful facial and total body repigmentation as shown
by greater proportions of patients reaching the facial and total
body Vitiligo Area Scoring (F-VASI and T-VASI, respectively)
endpoints at Week 52.
Specifically, efficacy results of patients who applied
ruxolitinib cream from Day 1 showed:
- At Week 52, approximately 50% of patients achieved ≥75%
improvement in the facial Vitiligo Area Scoring Index (F-VASI75)
compared to the F-VASI75 improvement from baseline reported for
these patients at Week 24 (the primary endpoint of the study) which
was approximately 30%.
- At Week 52, approximately 75% of patients achieved ≥50%
improvement in F-VASI (F-VASI50), and nearly one-third
(approximately 30%) achieved ≥90% improvement in F-VASI (F-VASI90)
compared to the Week 24 response rates for F-VASI50 and F-VASI90
which were approximately 51% and 15%, respectively.
- Additionally, a greater proportion of patients at Week 52
achieved ≥50% improvement in total body Vitiligo Area Scoring Index
(T-VASI50), and over one-third of patients achieved a Vitiligo
Noticeability Scale (VNS) response. Further improvement on
percentage change from baseline in facial body surface area (F-BSA)
with application of ruxolitinib cream was also observed.
Results at Week 52 in crossover patients (those who received 28
weeks of treatment with ruxolitinib cream after initial treatment
with vehicle cream) were consistent with Week 24 data in patients
who applied ruxolitinib cream from Day 1.
The overall safety profile of ruxolitinib cream in vitiligo was
consistent with previous study data – there were no clinically
significant application site reactions or serious treatment-related
adverse events related to ruxolitinib cream.
“The positive 52 week results in facial and total body
repigmentation seen with ruxolitinib cream in our pivotal Phase 3
TRuE-V program, which were presented today at the 2022 AAD meeting,
add to the robust data showing ruxolitinib cream has the potential
to be a meaningful treatment option for those with vitiligo,” said
Jim Lee, M.D., Ph.D., Group Vice President, Inflammation &
Autoimmunity, Incyte.
“Vitiligo is a serious and chronic autoimmune condition that can
severely impact a person’s life and has very limited treatments,”
said David Rosmarin, M.D., Vice Chair of Research and Education,
Department of Dermatology at Tufts Medical Center. “These results
are extremely encouraging and highlight the clinical potential of
ruxolitinib cream for patients with vitiligo.”
As previously announced, based on the 24-week results, Incyte
submitted marketing applications for ruxolitinib cream for the
treatment of adolescent and adult patients with vitiligo (age ≥12
years) to the U.S. Food and Drug Administration (FDA) and the
European Medicines Agency (EMA). The FDA Prescription Drug User Fee
Act (PDUFA) target action date is July 18, 2022.
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. Over-activity of the
JAK signaling pathway is believed to drive inflammation involved in
the pathogenesis and progression of vitiligo. It affects
approximately 1.9-2.8 million people in the United States1 and can
occur at any age, although many patients with vitiligo will
experience initial symptoms before the age of 30.2
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.
The studies each enrolled over 300 patients (age ≥12 years) who
have been diagnosed with non-segmental vitiligo and have
depigmented areas including at least 0.5% of the body surface area
(BSA) on the face, ≥0.5 facial Vitiligo Area Scoring Index [F-VASI]
score, at least 3% BSA on nonfacial areas, ≥3 total body Vitiligo
Area Scoring Index [T-VASI] score and total BSA involvement (facial
and nonfacial) of up to 10%. Participants were randomized into two
arms: 1.5% ruxolitinib cream twice daily (BID) and vehicle control
for the 24-week double-blind period. Patients who successfully
completed baseline and Week 24 assessments, including those that
received vehicle control during the double-blind phase, were
offered treatment extension with 1.5% ruxolitinib cream BID for an
additional 28 weeks.
The primary endpoint of both studies in the TRuE-V program is
the proportion of patients achieving F-VASI75, defined as at least
a 75% improvement from baseline in the F-VASI score at Week 24. Key
secondary endpoints include: the percentage change from baseline in
facial BSA (F-BSA) at Week 24, the proportion of patients achieving
F-VASI50 (at least 50% improvement from baseline in the F-VASI),
F-VASI90 (at least 90% improvement from baseline in the F-VASI) and
T-VASI50 (at least 50% improvement from baseline in the T-VASI) at
Week 24 and the proportion of patients achieving a Vitiligo
Noticeability Scale (VNS) score of 4 (a lot less noticeable) or 5
(no longer noticeable) at Week 24. Additional secondary endpoints
included the proportion of patients achieving F-VASI75, F-VASI90,
T-VASI50 and T-VASI75 (at least 75% improvement from baseline in
the T-VASI) at Week 52.The studies also track the frequency,
duration and severity of adverse events associated with the use of
ruxolitinib cream.
For more information on the TRuE-V studies, please visit
https://clinicaltrials.gov/ct2/show/NCT04052425 and
https://clinicaltrials.gov/ct2/show/NCT04057573.
About Ruxolitinib Cream (Opzelura™)
Ruxolitinib cream (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 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.
Incyte has worldwide rights for the development and
commercialization of ruxolitinib cream, marketed in the United
States as Opzelura. On October 28, 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 non-segmental
vitiligo with facial involvement.
Opzelura is a trademark of Incyte.
IMPORTANT SAFETY INFORMATION
OPZELURA cream is for use on the skin only. Do not use OPZELURA
cream in your eyes, mouth or vagina.
OPZELURA may cause serious side effects, including:
Serious Infections: OPZELURA cream 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 from all causes, including sudden
cardiac death, has happened in people taking 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. Some people have had lymphoma and other cancers while taking
JAK inhibitors by mouth, especially if they are a current or past
smoker. Some people have had skin cancers while taking OPZELURA.
Your healthcare provider will regularly check your skin during your
treatment with OPZELURA.
There is an increased risk of major cardiovascular events
such as heart attack, stroke or cardiac death in people with
cardiovascular risk factors and who are current or past smokers
while using JAK inhibitors to treat inflammatory
conditions.
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.
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 an
infection that 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) or 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 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 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 include: pain or
swelling in your nose or throat (nasopharyngitis), diarrhea,
bronchitis, ear infection, increase in a type of white blood cell
counts (eosinophil), hives, inflamed hair pores (folliculitis),
swelling of the tonsils (tonsilitis), and runny nose
(rhinorrhea).
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.
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 a number of immune-mediated dermatologic conditions with a high
unmet medical need, including vitiligo and 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 TRuE-V clinical program, whether and when
ruxolitinib cream might be approved to treat patients with
vitiligo, the potential for success of such treatment, 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 U.S. FDA and other
regulatory authorities outside of the United States; 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 on Form 10-K for the year ended December 31, 2021. The
Company disclaims any intent or obligation to update these
forward-looking statements.
1 Gandhi K, et al. Prevalence of vitiligo among adults in the
United States. JAMA Dermatol. 2022;158(1):43-50. 2 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/20220326005005/en/
Media Jenifer Antonacci +1 302 498 7036
jantonacci@incyte.com
Erica Cech +1 302 274 4324 ecech@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
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