- At approval, ruxolitinib cream will be the first treatment for
repigmentation in non-segmental vitiligo available in the European
Union (EU)
- In Europe, there are approximately 1.5 million patients
diagnosed with vitiligo, a progressive and complex disease with a
high unmet need
- The positive CHMP opinion is based on Phase 3 data showing
treatment with ruxolitinib cream resulted in improvements in facial
and total body repigmentation1
Incyte (Nasdaq:INCY) today announced that the European Medicines
Agency (EMA) Committee for Medicinal Products for Human Use (CHMP)
has issued a positive opinion recommending the approval of
ruxolitinib cream (Opzelura™) for the treatment of non-segmental
vitiligo with facial involvement in adults and adolescents from 12
years of age.
“The positive CHMP opinion brings us one step closer to bringing
ruxolitinib cream, the first ever treatment for repigmentation in
non-segmental vitiligo, to patients and healthcare professionals in
the European Union (EU),” said Steven Stein, M.D., Chief Medical
Officer, Chief Medical Officer, Incyte. “With no centrally approved
treatment option currently available in the EU, this positive
opinion marks a significant milestone for the vitiligo
community.”
The CHMP opinion recommending the approval of ruxolitinib cream
was based on data from two pivotal Phase 3 clinical trials (TRuE-V1
and TRuE-V2) evaluating the safety and efficacy of ruxolitinib
cream versus vehicle (non-medicated cream) in more than 600 people
with non-segmental vitiligo, age 12 and older1. Results from the
TRuE-V program, recently published in The New England Journal of
Medicine, showed that treatment with ruxolitinib cream resulted in
significant improvements in facial and total body repigmentation
versus vehicle as shown by the number of patients reaching the
facial and total body Vitiligo Area Scoring Index (F-VASI-T-VASI)
endpoints at Week 24 compared to vehicle, with a higher proportion
of patients responding at Week 521. The most common adverse
reactions (incidence ≥ 1%) were application site acne, application
site pruritus, nasopharyngitis, headache, urinary tract infection,
application site erythema, and pyrexia2.
The CHMP’s opinion is now being reviewed by the European
Commission, which has the authority to grant centralized marketing
authorizations for medicinal products in the EU. When approved,
this will be the first approved vitiligo therapy available in the
EU indicated for the treatment of non-segmental vitiligo with
facial involvement in adults and adolescents from 12 years of
age.
“Given its complex pathogenesis and unpredictable progression,
vitiligo can be very challenging for dermatologists to treat,” said
Thierry Passeron M.D., Ph.D., Professor and Chair, Department of
Dermatology, Université Côte d'Azur in Nice, France and one of the
lead investigators of the TRUE-V trials. “I welcome today’s news
and look forward to the potential approval of an effective therapy
that can address repigmentation, providing a much-needed option for
those patients living with vitiligo who are actively seeking
treatment, as well as the clinical community dedicated to its
treatment.”
About Vitiligo Vitiligo is a chronic autoimmune disease
characterized by depigmentation of skin that results in patchy loss
of skin color from the progressive destruction of pigment-producing
cells known as melanocytes. Overactivity of the JAK signaling
pathway is believed to drive inflammation involved in the
pathogenesis and progression of vitiligo. In Europe, approximately
1.5 million patients are diagnosed with vitiligo (0.2 to 0.8% of
the population3,4), and its overall prevalence is estimated to be
less than 1%, with the majority of patients (approximately 8 in 10)
suffering from non-segmental vitiligo5. Vitiligo can occur at any
age, although many patients with vitiligo will experience initial
onset before the age of 306. Vitiligo not only impacts physical
health but also places a heavy burden on quality of life including
employment and psychosocial health such as depression.
About TRuE-V The TRuE-V clinical trial program includes
two Phase 3 studies, TRuE-V1 (NCT04052425) and TRuE-V2
(NCT04057573), evaluating the safety and efficacy of ruxolitinib
cream in patients with vitiligo. Each study enrolled approximately
300 patients (age ≥12 years) who have been diagnosed with
non-segmental vitiligo.
About Ruxolitinib Cream (Opzelura™) Ruxolitinib cream
(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.
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 trademark of Incyte.
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 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 whether and when
ruxolitinib cream might be approved in the EU to treat patients
with vitiligo, the potential for success of such treatment,
Incyte’s TRuE-V clinical program 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 and the ability to enroll subjects in accordance with
planned schedules; the effects of the COVID-19 pandemic and
measures to address the pandemic on the Company’s clinical trials,
supply chain, and other third-party providers and development and
discovery operations; determinations made by the European
Commission and other regulatory authorities; 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; and other risks
detailed from time to time in the Company’s reports filed with the
U.S. Securities and Exchange Commission, including its annual
report for the year ending December 31, 2022. The Company disclaims
any intent or obligation to update these forward-looking
statements.
____________________________ 1 Rosmarin D, et al. Two Phase 3
Randomized Controlled Trials of Ruxolitinib Cream for Vitiligo. New
England Journal of Medicine. 2022; 387:1445-1455. 2 Opzelura
Prescribing Information. Wilmington, DE. Incyte Corporation. 3 Mohr
N, et al. Epidemiology of Vitiligo - A Dual Population-Based
Approach. Clinical Epidemiology. 2021 May 26;13:373-382. 4 Bibeau
K, et al. Vitiligo prevalence and quality of life among adults in
Europe, Japan and the USA. Journal of the European Academy of
Dermatology and Venerology. 2022 V36(10), P 1831-1844 5 Gandhi K,
et al. Prevalence of Vitiligo Among Adults in the United States.
JAMA Dermatol. 2022 Jan 1;158(1):43-50. 6 Frisoli M, et al.
Vitiligo: mechanisms of pathogenesis and treatment. Annual Review
of Immunology. 2020;38(1):621-648.
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Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Ela Zawislak +41 21 343 3113 ezawislak@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
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