Incyte (Nasdaq:INCY) today announced that key data from across
its dermatology portfolio, including multiple late-breaking
abstracts, will be presented at the upcoming European Academy of
Dermatology and Venereology (EADV) Congress 2024 held September
25-28 in Amsterdam.
“We’re excited to present five late-breaking oral presentations
at this year’s congress, featuring data that could further expand
treatment options for those living with immune-mediated
dermatologic conditions, including vitiligo, atopic dermatitis,
hidradenitis suppurativa and prurigo nodularis,” said Pablo J.
Cagnoni, M.D., President and Head of Research and Development,
Incyte. “The data highlight our ongoing efforts to evaluate the
efficacy and safety of ruxolitinib cream in new patient
populations, as well as deepen our understanding of povorcitinib in
patients impacted by debilitating immune-mediated dermatologic
conditions.”
Key abstracts from Incyte-sponsored programs include:
Late-breaking Oral
Presentations
Vitiligo
Impact of Treatment Duration on Response Durability: A Post
Hoc Analysis of the TRuE-V Long-Term Extension Study of Ruxolitinib
Cream in Vitiligo Abstract #8077. Session: D2T01.3: Late
breaking news. Presentation Time: 9:15 – 9:30 a.m. ET (3:15 – 3:30
p.m. CET), September 26, 2024
Atopic Dermatitis
52-Week Safety and Disease Control With Ruxolitinib Cream in
Children Aged 2 to 11 Years With Atopic Dermatitis: Results From
the Phase 3 TRuE-AD3 Study Abstract #8082. Session: D2T01.4:
Late breaking news. Presentation Time: 10:00 – 10:15 a.m. ET (4:00
– 4:15 p.m. CET), September 26, 2024
Hidradenitis Suppurativa
Ruxolitinib Cream for Mild-to-Moderate Hidradenitis
Suppurativa: 32-Week Data From a Randomized Phase 2 Study
Abstract #8071. Session: D2T01.3: Late breaking news. Presentation
Time: 9:00 – 9:15 p.m. ET (3:00 – 3:15 p.m. CET), September 26,
2024
Prurigo Nodularis
Efficacy and Safety of Oral Povorcitinib in Patients With
Prurigo Nodularis: 40-Week Results From a Randomized, Double-Blind,
Placebo-Controlled Phase 2 Study Abstract #8081. Session:
D2T01.3: Late breaking news. Presentation Time: 9:30 – 9:45 a.m. ET
(3:30 – 3:45 p.m. CET), September 26, 2024
Lichen Planus
Efficacy and Safety of Ruxolitinib Cream in Patients With
Cutaneous Lichen Planus: Results From a Phase 2, Randomized,
Vehicle-Controlled Study Abstract #7974. Session: D3T01.4: Late
breaking news. Presentation Time: 10:30 – 10:45 a.m. ET (4:30 –
4:45 p.m. CET), September 27, 2024
ePosters
Vitiligo
Efficacy and Safety of Ruxolitinib Cream for the Treatment of
Vitiligo Through 2 Years in the TRuE-V Studies Poster
#P2983.
Characterizing Maintenance of Repigmentation in a Post Hoc
Analysis of the TRuE-V Long-Term Extension Study of Ruxolitinib
Cream in Vitiligo Poster #P2984.
Effect of Povorcitinib on Achievement of VASI50 by Body
Region in Patients With Extensive Nonsegmental Vitiligo: Post Hoc
Analysis of a 52-Week Phase 2 Study Poster #P3016.
Effect of Povorcitinib on Achievement of VESplus50 by Body
Region in Patients With Extensive Nonsegmental Vitiligo: Post Hoc
Analysis of a 52-Week Phase 2 Study Poster #P3017.
Full session details and data presentation listings, please see
the EADV 2024 Congress online program here:
https://eadvapps.m-anage.com/eadvcongress2024/en-GB/pag/
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 and Europe 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 3 clinical trials for vitiligo,
hidradenitis suppurativa (HS) and prurigo nodularis.
About Incyte
A global biopharmaceutical company on a mission to Solve On.,
Incyte follows the science to find solutions for patients with
unmet medical needs. Through the discovery, development and
commercialization of proprietary therapeutics, Incyte has
established a portfolio of first-in-class medicines for patients
and a strong pipeline of products in Oncology and Inflammation
& Autoimmunity. Headquartered in Wilmington, Delaware, Incyte
has operations in North America, Europe and Asia.
For additional information on Incyte, please visit Incyte.com or
follow us on social media: LinkedIn, X, Instagram, Facebook,
YouTube.
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, the promise presented by that 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 our current
expectations and are 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;
determinations made by the FDA and regulatory agencies outside of
the United States; the efficacy or safety of our products; the
acceptance of our products in the marketplace; market competition;
unexpected variations in the demand for our products and the
products of our collaboration partners; the effects of announced or
unexpected price regulation or limitations on reimbursement or
coverage for our products; sales, marketing, manufacturing, and
distribution requirements, including our ability to successfully
commercialize and build commercial infrastructure for newly
approved products and any additional new products that become
approved; and other risks detailed from time to time in our reports
filed with the U.S. Securities and Exchange Commission, including
our annual report on Form 10-K and our quarterly report on Form
10-Q for the quarter ended June 30, 2024. We disclaim any intent or
obligation to update these forward-looking statements.
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