Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug
Administration (FDA) has accepted for Priority Review the
supplemental New Drug Application (sNDA) for ruxolitinib cream 1.5%
(Opzelura™) a topical JAK inhibitor, as a potential treatment for
adolescents and adults (age ≥12 years) with vitiligo. The FDA
grants Priority Review to medicines that may offer a major advance
in treatment where none currently exists. The Prescription Drug
User Fee Act (PDUFA) target action date is April 18, 2022.
“Vitiligo is a chronic autoimmune disease that can have a
profound impact on people’s lives,” said Jim Lee, M.D., Ph.D.,
Group Vice President, Inflammation & Autoimmunity, Incyte.
“Currently, there are no FDA-approved drug therapies for
repigmentation in people with vitiligo. The FDA’s acceptance of our
sNDA for ruxolitinib cream brings us one step closer to offering
patients with vitiligo an additional treatment option.”
The sNDA is supported by data from the Phase 3 TRuE-V clinical
trial program evaluating the safety and efficacy of ruxolitinib
cream in more than 600 people with non-segmental vitiligo, age 12
and older. Results from the Phase 3 program were recently presented
at the 30th European Academy of Dermatology and Venereology (EADV)
congress during a late-breaking research session. The data showed
that at Week 24, 29.9% of patients applying ruxolitinib cream
achieved ≥75% improvement from baseline in the facial Vitiligo Area
Scoring Index (F-VASI75), the primary endpoint.
In September 2021, Opzelura™ (ruxolitinib) cream 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. Use of
Opzelura™ in combination with therapeutic biologics, other JAK
inhibitors or potent immunosuppressants such as azathioprine or
cyclosporine is not recommended.
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 1.5 million+ people in the U.S.1 and there are no
U.S. Food and Drug Administration (FDA)-approved drug therapies for
repigmentation in vitiligo. It can occur at any age, although many
patients with vitiligo will experience initial symptoms before the
age of 20.2
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 approximately 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 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, 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, and the percentage change from
baseline in facial BSA (F-BSA) at Week 24. 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 or had 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 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 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
(eosinophil) count, hives, inflamed hair pores (folliculitis),
swelling of the tonsils (tonsillitis), 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 whether and when ruxolitinib cream might be approved to
treat patients with vitiligo, the potential for success of such
treatment, 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 September 30, 2021. The Company
disclaims any intent or obligation to update these forward-looking
statements.
1 Bowcock, A; Fernandez-Vina, M. Targeting Skin: Vitiligo and
Autoimmunity. J Invest Dermatol.
https://www.sciencedirect.com/science/article/pii/S0022202X1535452X.
Accessed November 22, 2021. 2 Rodrigues M. New discoveries in the
pathogenesis and classification of vitiligo. J Am Acad Dermatol.
2017; 77:1-13.
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version on businesswire.com: https://www.businesswire.com/news/home/20211214006227/en/
Incyte: 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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