Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug
Administration (FDA) has accepted for Priority Review the New Drug
Application (NDA) for ruxolitinib cream, a selective JAK1/JAK2
inhibitor designed for topical application, as a treatment for
atopic dermatitis (AD), a type of eczema.
“Incyte’s deep understanding of the pathways involved in
immune-mediated skin conditions led us to investigate the potential
for ruxolitinib cream to address key factors associated with atopic
dermatitis, that is, inflammation of the skin and itch,” said Jim
Lee, M.D., Ph.D., Group Vice President, Inflammation &
Autoimmunity, Incyte. “We are grateful to the people living with
atopic dermatitis whose participation in our clinical trials helped
generate the evidence to support this regulatory submission, and we
look forward to working with the FDA as we seek to bring forward a
new topical treatment for people living with this chronic skin
disease.”
The NDA is supported by data from the Phase 3 TRuE-AD clinical
trial program, which included more than 1,200 people, age 12 years
and older. Primary efficacy and safety results from both TRuE-AD
trials were presented at the Revolutionizing Atopic Dermatitis
Virtual Symposium in April 2020. Additional safety and efficacy
data from the 44-week, open-label, long-term extension of both
TRuE-AD1 and TRuE-AD2 were included in the NDA.
Incyte submitted a priority review voucher (PRV) along with the
NDA application for ruxolitinib cream. The use of the PRV shortens
the review period by four months. The Prescription Drug User Fee
Act (PDUFA) target action date is June 21, 2021.
About Atopic Dermatitis Atopic dermatitis (AD) is a
chronic skin disease, affecting more than 21 million people in the
United States and is characterized by inflammation and intense
itch. Signs and symptoms of AD include irritated and itchy skin
that can cause red lesions that may ooze and crust. Patients with
AD are also more susceptible to bacterial, viral and fungal
infections.
About TRuE-AD The TRuE-AD clinical trial program consists
of two randomized, double-blind, vehicle-controlled Phase 3
studies, TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651),
evaluating the safety and efficacy of ruxolitinib cream compared to
vehicle (non-medicated cream) in patients with atopic dermatitis
(AD). Both studies enrolled more than 600 patients (age ≥12 years)
diagnosed with AD for at least two years and who were candidates
for topical therapy.
Patients with an Investigator’s Global Assessment (IGA) score of
2 to 3, and with AD on 3% to 20% of their Body Surface Area
(excluding scalp) were randomized 2:2:1 into one of three arms for
eight weeks: ruxolitinib cream 0.75% applied twice daily (BID);
ruxolitinib cream 1.5% applied BID; and vehicle. Participants who
successfully completed an assessment at Week 8 were offered
participation in the 44-week long-term safety treatment extension
period with ruxolitinib cream 0.75% or 1.5% applied BID.
The primary endpoint of the TRuE-AD studies was the proportion
of participants achieving an Investigator’s Global Assessment
Treatment Success (IGA-TS), defined as an IGA score of 0 (clear) or
1 (almost clear) with at least a 2-point improvement from baseline
at Week 8. Key secondary endpoints include: the proportion of
patients achieving at least a 75% improvement from baseline in the
Eczema Area and Severity Index (EASI-75) score, the proportion of
participants with at least a 4-point improvement in the itch
Numerical Rating Scale, and the proportion of participants with at
least a 6-point improvement in the Patient-Reported Outcomes
Measurement Information System (PROMIS) Short Form – Sleep
Disturbance (8b) 24-hour recall score. Additional secondary
endpoints include mean percentage change from baseline in Scoring
Atopic Dermatitis (SCORAD) score. The studies have also been
tracking the frequency, duration and severity of adverse events
associated with the use of ruxolitinib cream.
TRuE-AD results presented at the 29th European Academy of
Dermatology and Venereology (EADV) Congress in October 2020
examined sleep quality, sleep depth and restoration associated with
sleep, key quality of life measures for people with AD.
For more information about the TRuE-AD studies, please visit
http://clinicaltrials.gov/ct2/show/NCT03745638 and
http://clinicaltrials.gov/ct2/show/NCT03745651.
About Ruxolitinib Cream Ruxolitinib cream is a
proprietary formulation of Incyte’s selective JAK1/JAK2 inhibitor
ruxolitinib that has been designed for topical application.
Ruxolitinib cream is currently in Phase 3 development for the
treatment of atopic dermatitis (TRuE-AD) and for the treatment of
adolescents and adults with vitiligo (TRuE-V). Incyte has worldwide
rights for the development and commercialization of ruxolitinib
cream.
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 atopic dermatitis, 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 Company’s ongoing
clinical development program for ruxolitinib cream as well as its
dermatology program generally, and whether and when ruxolitinib
cream will be approved for use in the U.S. or elsewhere for atopic
dermatitis or any other indication, 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; determinations made by the FDA; the Company’s dependence on
its relationships with its collaboration partners; the efficacy or
safety of the Company’s products and the products of the Company’s
collaboration partners; the acceptance of the Company’s products
and the products of the Company’s collaboration partners in the
marketplace; market competition; sales, marketing, manufacturing
and distribution requirements; greater than expected expenses;
expenses relating to litigation or strategic activities; and other
risks detailed from time to time in the Company’s reports filed
with the Securities and Exchange Commission, including its Form
10-K for the year ended December 31, 2020. 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/20210219005026/en/
Incyte: Media Jenifer
Antonacci +1 302 498 7036 jantonacci@incyte.com
Catalina Loveman +1 302 498 6171 cloveman@incyte.com
Kathleen Cuca +1 302 498 7886 kcuca@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
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