- Opzelura is the first and only topical Janus
kinase (JAK) inhibitor approved in the United States
- In Phase 3 studies, Opzelura significantly
reduced the skin inflammation and itch associated with AD
- Investor conference call and webcast
scheduled for September 22, 2021, at 8:00 a.m. ET
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug
Administration (FDA) has approved Opzelura™ (ruxolitinib) cream for
the 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. Opzelura is the first and only topical
formulation of a JAK inhibitor approved in the United States.
Research shows dysregulation of the JAK-STAT pathway contributes to
key features of AD such as itch, inflammation and skin barrier
dysfunction1.
“Atopic dermatitis is a chronic immune-mediated disease that can
be challenging to manage. Many patients do not respond well to
existing treatments and have uncontrolled disease,” said Jonathan
Silverberg, M.D., Ph.D., M.P.H., Associate Professor of Dermatology
and Director of Clinical Research and Contact Dermatitis at The
George Washington University School of Medicine and Health
Sciences. “As a clinician, I am excited to have a non-steroidal
topical cream like Opzelura.”
“The approval of Opzelura is an important advancement in the
treatment of AD, and we are pleased to offer a novel topical
treatment option that targets a pathway believed to be a source of
inflammation,” said Hervé Hoppenot, Chief Executive Officer,
Incyte. “At Incyte, we are committed to transforming the treatment
of immune-mediated dermatologic conditions like AD. We look forward
to bringing Opzelura to the patient community and also continuing
to explore its potential in other challenging skin diseases.”
The FDA approval was based on data from the TRuE-AD (Topical
Ruxolitinib Evaluation in Atopic Dermatitis) clinical trial
program, consisting of two randomized, double-blind,
vehicle-controlled Phase 3 studies (TRuE-AD1 and TRuE-AD 2)
evaluating the safety and efficacy of Opzelura in more than 1,200
adolescents and adults with mild to moderate AD. Results from the
studies showed patients experienced significantly clearer skin and
itch reduction when treated with Opzelura cream 1.5% twice daily
(BID), compared to vehicle (non-medicated cream):
- Significantly more patients treated with Opzelura achieved
Investigator’s Global Assessment (IGA) Treatment Success (IGA-TS,
primary endpoint) at Week 8 (defined as an IGA score of 0 [clear]
or 1 [almost clear] with at least a 2-point improvement from
baseline): 53.8% in TRuE-AD1 and 51.3% in TRuE-AD2, compared to
vehicle (15.1% in TRuE-AD1, 7.6% in TRuE-AD2; P<0.0001).
- Significantly more patients treated with Opzelura experienced a
clinically meaningful reduction in itch from baseline at Week 8, as
measured by a ≥4-point reduction in the itch Numerical Rating Scale
(itch NRS4): 52.2% in TRuE-AD1 and 50.7% in TRuE-AD2, compared to
vehicle (15.4% in TRuE-AD1, 16.3% in TRuE-AD2; P<0.0001), among
patients with an NRS score of at least 4 at baseline.
In clinical trials, the most common (≥1%) treatment-emergent
adverse reactions in patients treated with Opzelura were
nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil
count increased, urticaria, folliculitis, tonsillitis and
rhinorrhea2. See Important Safety Information below, including
Boxed Warnings for serious infections, mortality, malignancy, major
adverse cardiovascular events and thrombosis, seen with JAK
inhibitors for inflammatory conditions.
“It can be hard for people to fully appreciate how difficult AD
can be and the tremendous impact it has on patients,” said Julie
Block, President & CEO, National Eczema Association. “The
chronic itch is difficult to cope with and related sleep issues can
be exhausting. Many patients and their dermatologists are looking
for additional options to meet current unmet needs in the
management of AD. The approval of Opzelura is exciting news, and we
welcome a new treatment option for our community.”
AD is a chronic skin disease affecting more than 21 million
people aged 12 years and older in the U.S. and is characterized by
inflammation and itch3. Signs and symptoms include irritated and
itchy skin that can cause red lesions that may ooze and crust.
People with AD are also more susceptible to bacterial, viral and
fungal infections4.
Incyte is committed to supporting patients and removing barriers
to access medicines. Eligible patients in the U.S. 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
1-855-452-5234, Monday through Friday, from 8 a.m. to 8 p.m.
ET.
Conference Call Information
Incyte will host an analyst and investor conference call and
webcast on September 22, 2021, at 8:00 a.m. ET. 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 +1-201-389-0864 for international callers
(conference identification number 13723195).
If you are unable to participate, a replay will be available for
90 days. The replay dial-in number for the United States is
877-660-6853 and the dial-in number for international callers is
+1-201-612-7415 (conference identification number 13723195).
About TRuE-AD
The TRuE-AD clinical trial program evaluating the safety and
efficacy of ruxolitinib cream compared to vehicle (non-medicated
cream) in patients with atopic dermatitis (AD) consists of two
randomized, double-blind, vehicle-controlled Phase 3 studies:
TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651). Both studies
enrolled more than 600 patients (age ≥12 years) who had been
previously diagnosed with AD for at least two years and who were
candidates for topical therapy.
Key findings from the TRuE-AD1 and TRuE-AD2 studies were
presented at the European Academy of Dermatology and Venereology
(EADV) Congress, Revolutionizing Atopic Dermatitis Virtual
Symposium and previously announced by Incyte.
About 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.
Additionally, ruxolitinib cream is in Phase 3 development for
the treatment of adolescents and adults with vitiligo in the TRuE-V
clinical program. Results from this Phase 3 program were recently
announced.
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 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 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
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 whether or when Opzelura might provide a successful
treatment option for patients with atopic dermatitis, the Company’s
ongoing clinical development program for ruxolitinib cream and its
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 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 or 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 June 30, 2021. The
Company disclaims any intent or obligation to update these
forward-looking statements.
________________________________ 1 Bao L, et al. JAK-STAT.
2013;2(3):e24137. doi:10.4161/jkst.24137. 2 Ruxolitinib cream
Prescribing Information. Wilmington, DE. Incyte Corporation. 3 U.S.
Census Bureau (2020). 2020 Decennial Census. Retrieved from
https://data.census.gov/cedsci/table?q=Populations%20and%20People&tid=DECENNIALPL2020.P1
[data.census.gov]. 4 Boguniewicz M, et al. Ann Allergy Asthma
Immunol. 2018;120(1):10-22.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210921006072/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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