- New data on ruxolitinib cream (Opzelura™) in vitiligo and
atopic dermatitis will be presented, including 52-week results from
the Phase 3 TRuE-V vitiligo program which will be featured as a
late-breaking oral presentation
Incyte (Nasdaq:INCY) today announced that multiple abstracts
featuring data from its dermatology portfolio will be presented at
the upcoming American Academy of Dermatology (AAD) Annual Meeting,
held March 25-29, 2022, in Boston.
New 52-week data from the Phase 3 TRuE-V vitiligo program
evaluating the safety and efficacy of ruxolitinib cream in
adolescent and adult patients (age ≥12 years) with vitiligo will be
presented as an oral presentation in a late-breaking abstract
session. Incyte previously announced positive 24-week results from
the TRuE-V1 and TRuE-V2 studies.
“We are pleased to convene again at AAD 2022 and present new
ruxolitinib cream data which highlights its potential for patients
with atopic dermatitis and vitiligo and our commitment to the
Dermatology community,” said Jim Lee, M.D., Ph.D., Group Vice
President, Inflammation & Autoimmunity, Incyte. “We look
forward to sharing data from multiple Phase 3 studies highlighting
clinical trial data for ruxolitinib cream – notably the 52-week
results from the TRuE-V vitiligo program – as well as findings from
the VALIANT study which contribute to the scientific understanding
of the natural history of vitiligo and its burden on patients in
the United States.”
Key abstracts include:
Late-Breaking Oral
Presentation
Vitiligo
Efficacy and Safety of Ruxolitinib Cream Monotherapy for the
Treatment of Vitiligo: Results from Two 52-Week Phase 3 Studies
(Session: S026 – Late-Breaking Research: Clinical Trials. Saturday,
March 26, 10:40 a.m. ET)
Posters with Oral
Presentation
Atopic Dermatitis
Efficacy of Ruxolitinib Cream for the Treatment of Atopic
Dermatitis by Anatomic Region: Pooled Analysis From Two Randomized
Phase 3 Studies (Category: Atopic Dermatitis)
Vitiligo
Efficacy and Safety of Ruxolitinib Cream for the Treatment of
Vitiligo: Week 24 Pooled Analysis of the TRuE-V Phase 3 Studies
(Category: Pigmentary Disorders & Vitiligo)
Efficacy and Safety of Ruxolitinib Cream for the Treatment of
Vitiligo by Patient Demographics and Baseline Clinical
Characteristics: Pooled Subgroup Analysis From Two Randomized Phase
3 Studies (Category: Pigmentary Disorders & Vitiligo)
The Mental Health and Psychosocial Burden Among Patients
Living With Vitiligo in the United States: Findings From the
VALIANT Study (Category: Pigmentary Disorders &
Vitiligo)
Poster Presentations
Atopic Dermatitis
Long-Term Safety and Disease Control of Ruxolitinib Cream
Among Black or African American Patients With Atopic Dermatitis:
Pooled Results From Two Phase 3 Studies (Abstract #34794.
Friday, March 25, 2022 - Sunday, March 27, 2022, 9:00 a.m. – 5:00
p.m. ET; ePoster only)
Ruxolitinib Cream Provided Progressive Improvement in
Patients With Atopic Dermatitis Who Did Not Achieve Investigator’s
Global Assessment Treatment Success at Week 8: Pooled Results From
Two Phase 3 Studies (Abstract #35163. Friday, March 25, 2022 -
Sunday, March 27, 2022, 9:00 a.m. – 5:00 p.m. ET; ePoster only)
Vitiligo
Exploring the Natural History of Vitiligo in the United
States: Findings From the VALIANT Study (Abstract #34612.
Friday, March 25, 2022 - Sunday, March 27, 2022, 9:00 a.m. – 5:00
p.m. ET; ePoster only)
Do Patients With Vitiligo and Healthcare Professionals
Treating Them Recognize the Burden in Living With the Disease in
the United States? Findings From the VALIANT Study (Abstract
#34631. Friday, March 25, 2022 - Sunday, March 27, 2022, 9:00 a.m.
– 5:00 p.m. ET; ePoster only)
Full abstracts will be available on the AAD website on March 25,
2022. More information regarding the 2022 AAD Annual Meeting can be
found at https://www.aad.org/member/meetings-education/am22.
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.
In October 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. Additionally,
in December 2021, Incyte announced the acceptance and priority
review of the supplemental New Drug Application (sNDA) for
ruxolitinib cream as a potential treatment for adolescents and
adults (age ≥12 years) with vitiligo.
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.
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 the potential of Opzelura to provide a successful
treatment for atopic dermatitis, whether and when ruxolitinib cream
might be approved to treat patients with vitiligo, the potential
for success of such treatment, Incyte’s clinical trials 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 December 31, 2021. The Company
disclaims any intent or obligation to update these forward-looking
statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20220318005248/en/
Media Catalina Loveman +1 302 498 6171
cloveman@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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