Incyte (Nasdaq:INCY) announced today its partnership with
actress, singer and songwriter Mandy Moore on Moments of Clarity,
an educational initiative highlighting the authentic stories of
people living with mild to moderate atopic dermatitis (AD) and
their journey to finding relief from their AD symptoms. AD, the
most common form of eczema, is a chronic condition characterized by
inflammation of the skin which can manifest as persistent itch, dry
and scaly patches or red lesions on the body1.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20231011336627/en/
(Photo: Business Wire)
As someone who also lives with eczema, Mandy Moore understands
the challenges of the condition. Through Moments of Clarity, Mandy
encourages others with eczema to take charge of their health and
talk to their dermatologists about finding an appropriate
treatment.
"A few years ago, I noticed that the skin around my eyes was
itchy, inflamed and peeling. After seeing a dermatologist, I was
diagnosed with eczema," said Mandy Moore. “I chose to partner with
Incyte because I know how difficult it is to live with a chronic
condition like eczema, and I want to empower others to find relief
from their symptoms by speaking with their health care providers to
learn more about treatment options."
While every person’s experience with AD is different, there are
defining moments in everyone’s journey that can bring them clarity
– from getting an accurate diagnosis, to speaking with a
dermatologist, to finding the right treatment that meets their
goals. Moments of Clarity features stories of people with mild to
moderate eczema who after realizing they needed relief from their
symptoms, sought help from a dermatologist and are being treated
with Opzelura® (ruxolitinib) cream 1.5%*. Opzelura is indicated for
the topical short-term and non-continuous chronic treatment of mild
to moderate atopic dermatitis in non-immunocompromised adult and
pediatric patients 12 years of age and older whose disease is not
adequately controlled with topical prescription therapies or when
those therapies are not advisable.
“This program underscores Incyte’s commitment to people with AD,
and we hope these stories encourage people living with the
condition to have a conversation with their dermatologist about
their treatment goals,” said Barry Flannelly, Executive Vice
President and General Manager, North America, Incyte. “We are
grateful to Mandy Moore for partnering with us and lending her
voice to help others know they are not alone in their
journeys.”
To learn more, visit MyMomentsofClarity.com.
* Mandy Moore has been compensated for her participation. Mandy
Moore has not been prescribed Opzelura.
About Atopic Dermatitis
Atopic dermatitis (AD) – the most common type of eczema – 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 itch2. 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
infections3.
About Opzelura® (ruxolitinib) Cream
Opzelura® (ruxolitinib) cream, 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.
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 registered 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, 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 partnership between Incyte and Mandy Moore, Incyte’s
goal of improving the lives of patients, whether and when Opzelura
might provide a successful treatment options for patients with
atopic dermatitis, and Incyte’s dermatology program generally,
contain predictions, estimates and other forward-looking
statements.
These forward-looking statements are based on Incyte’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;
determinations made by the FDA and other regulatory authorities
outside of the United States; the efficacy or safety of Incyte’s
products; the acceptance of Incyte’s products in the marketplace;
market competition; sales, marketing, manufacturing and
distribution requirements; and other risks detailed from time to
time in Incyte’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, 2023. Incyte disclaims any
intent or obligation to update these forward-looking
statements.
_____________________________
1 National Eczema Association. What is
atopic dermatitis?
https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/
2 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].
3 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/20231011336627/en/
Media
Jenifer Antonacci +1 302 498 7036 jantonacci@incyte.com
Erica Cech +1 302 274 4324 ecech@incyte.com
Investors
Greg Shertzer +1 302 274 4779 gshertzer@incyte.com
Incyte (NASDAQ:INCY)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Incyte (NASDAQ:INCY)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024