Incyte (Nasdaq:INCY) today announced multiple abstracts
featuring new data from across its dermatology portfolio have been
accepted for presentation at the upcoming European Academy of
Dermatology and Venereology (EADV) Congress 2023 held October 11-14
in Berlin.
“We are pleased to add to the data supporting the use of
ruxolitinib cream for patients living with vitiligo and atopic
dermatitis (AD) through two late-breaking presentations – one on
prolonged use of treatment in vitiligo patients with limited or no
initial response, and the full results of our TRuE-AD3 trial in
pediatric AD,” said Jim Lee, M.D., Ph.D., Group Vice President,
Inflammation & Autoimmunity, Incyte. “Collectively, the data at
this year's Congress, which also include new late-breaking data for
povorcitinib in vitiligo, emphasize our ongoing efforts to advance
treatment options for the Dermatology community."
Key abstracts from Incyte-sponsored programs include:
Late-breaking Oral
Presentations
Vitiligo
Efficacy and Safety of Povorcitinib for Extensive Vitiligo:
52-Week Results from a Double-Blinded, Placebo-Controlled,
Dose-Ranging Phase 2b Study (Abstract #6749. Session: D1T01.1A:
Late Breaking News. Wednesday, October 11, 8:15 a.m. – 8:30 a.m.
ET)
Efficacy of Prolonged Ruxolitinib Cream Treatment for
Vitiligo Among Patients with Limited or No Initial Response at 6
Months (Abstract #6479. Session: D1T01.1I: Late Breaking News.
Wednesday, October 11, 10:30 a.m. – 10:45 a.m. ET)
Atopic Dermatitis (AD)
A Phase 3 Study of Ruxolitinib Cream in Children Aged
2–<12 Years with Atopic Dermatitis (TRuE-AD3): 8-Week
Analysis (Abstract #6746. Session: D3T01.3I: Late Breaking
News. Friday, October 13, 10:30 a.m. – 10:45 a.m. ET)
Oral Presentations
Hidradenitis Suppurativa
Baseline Demographic and Disease Characteristics Associated
with Achieving HiSCR with Povorcitinib: Secondary Analysis from a
Phase 2, Randomized, Placebo-Controlled Clinical Trial
(Abstract #2803. Session: FC02.1: Free Communications II. Thursday,
October 12, 4:15 a.m. – 4:25 a.m. ET)
Impact of Povorcitinib on DLQI and DLQI Subdomains in
Patients with Hidradenitis Suppurativa: Results from a Randomized,
Placebo-Controlled Phase 2 Study (Abstract #2795. Session:
FC02.2: Free Communications II. Thursday, October 12, 4:25 a.m. –
4:35 a.m. ET)
ePosters
Vitiligo
Effect of Ruxolitinib Cream on VASI-50 Achievement by Body
Region Through Week 104 in Patients with Vitiligo: Analysis of the
TRuE-V Long-Term Extension Phase 3 Study (Abstract #926)
Efficacy and Safety of Ruxolitinib Cream Through Week 104 in
Patients with Vitiligo: Subgroup Analysis of the TRuE-V Long-Term
Extension Phase 3 Study (Abstract #927)
Characterization and Treatment of Acne that Occurred Among
Individuals with Vitiligo who Applied Ruxolitinib Cream in Two
Randomized Phase 3 Trials (Abstract #2595)
Depression and Depressive Symptoms Among Persons Living with
Vitiligo: Findings from the Global VALIANT Survey (Abstract
#2572)
Treatment Satisfaction, Breaks and Cessation Among Patients
Living with Vitiligo: Findings from the Global VALIANT Survey
(Abstract #2579)
Retrospective Database Analysis on the Treatment Patterns in
Patients with Vitiligo in Quebec, Canada (Abstract #2591)
Epidemiology and Comorbidity of Patients with Vitiligo in
Germany (Abstract #3072)
AD
A Maximum-Use Trial of Ruxolitinib Cream in Children Aged ≥2
years to <12 Years with Atopic Dermatitis: 8-Week Analysis
(Abstract #2551)
Rapid, Substantial and Sustained Reduction of Itch in Adults
with Atopic Dermatitis Applying Ruxolitinib Cream — Clinical and
Translational Results from the Open-Label Phase 2 SCRATCH-AD
Study (Abstract #2813)
For full session details and data presentation listings, please
see the EADV Congress 2023
(https://eadvcongress2023.org/scientific/) online program.
About Opzelura® (ruxolitinib) Cream 1.5% Opzelura, 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.
In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for
the treatment of non-segmental vitiligo with facial involvement in
adults and adolescents from 12 years of age.
Incyte has worldwide rights for the development and
commercialization of ruxolitinib cream, marketed in the United
States as Opzelura.
Opzelura and the Opzelura logo are registered trademarks of
Incyte.
About Povorcitinib (INCB54707) Povorcitinib (INCB54707)
is an oral small-molecule JAK1 inhibitor currently in Phase 2
clinical trials for vitiligo, hidradenitis suppurativa (HS),
prurigo nodularis, chronic spontaneous urticaria and asthma. Phase
3 studies in HS are also ongoing.
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, hidradenitis
suppurativa, 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 presentation of data
from Incyte’s clinical development pipeline, whether or when any
development compounds or combinations will be approved or
commercially available for use in humans anywhere in the world
outside of the already approved indications in specific regions,
and Incyte’s goal of improving the lives of patients, 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, EMA and other regulatory
authorities; 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 September 30, 2023. Incyte disclaims any
intent or obligation to update these forward-looking
statements.
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Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Investors Greg Shertzer +1 302 498 4779
gshertzer@incyte.com
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