- Opzelura® (ruxolitinib) Cream is the first approved treatment
in the European Union (EU) to address repigmentation in
non-segmental vitiligo
- Phase 3 data supporting the approval show treatment with
Opzelura resulted in improved facial and total body repigmentation,
sustained and continued improvements with longer duration of
treatment
Incyte (Nasdaq:INCY) today announced that the European
Commission (EC) has granted a marketing authorization for Opzelura®
(ruxolitinib) cream 15mg/g for the treatment of non-segmental
vitiligo with facial involvement in adults and adolescents from 12
years of age. Opzelura is the first and only approved treatment in
the European Union (EU) to offer support for repigmentation in
eligible patients with non-segmental vitiligo, a chronic autoimmune
disease characterized by depigmentation of skin and reduced quality
of life.
The EC decision follows the positive opinion received from the
European Medicines Agency’s Committee for Medicinal Products for
Human Use (CHMP) earlier this year and is applicable to all 27
European Union Member States, Iceland, Norway and
Liechtenstein.
“The approval of Opzelura by the European Commission represents
a significant advancement for people living with non-segmental
vitiligo with facial involvement who, until now, had no approved
medical treatment to address repigmentation,” said Hervé Hoppenot,
Chief Executive Officer, Incyte. “This approval wouldn’t have been
possible without the support of the vitiligo patient and medical
community, and the efforts of our research and development teams.
We will now work across individual countries in Europe to bring
this much awaited therapy to eligible patients seeking to treat
their vitiligo.”
The EC decision is based on data from two pivotal Phase 3
clinical trials (TRuE-V1 [NCT04052425] and TRuE-V2 [NCT04057573]),
evaluating the efficacy and safety of Opzelura versus vehicle
(non-medicated cream) in more than 600 people with non-segmental
vitiligo, age 12 and older. Results from the TRuE-V program showed
that treatment with Opzelura 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 and in an open-label extension at Week 521.
Results at Week 24, which were consistent across both studies,
showed that 29.8% and 30.9% of patients treated with Opzelura
achieved ≥75% improvement from baseline in the facial Vitiligo Area
Scoring Index (F-VASI75), the primary endpoint, compared to 7.4%
and 11.4% of patients treated with vehicle in TRuE-V1 and TRuE-V2,
respectively. At Week 52, approximately one in two of
Opzelura-treated patients achieved F-VASI751.
Additionally, at Week 24, more than 15% of patients treated with
Opzelura achieved ≥90% improvement from baseline in F-VASI
(F-VASI90), compared to approximately 2% of patients treated with
vehicle. At Week 52, approximately one in three of Opzelura-treated
patients achieved F-VASI90.
There were no serious treatment-related adverse events related
to ruxolitinib cream and the most common adverse reaction was
application site acne1.
Pivotal Phase 3 data supporting the European Commission decision
were also published in The New England Journal of Medicine.
“The approval of Opzelura is welcome news for dermatologists and
eligible patients in Europe who often face challenges managing
vitiligo,” said Prof. Dr. Markus B�hm, Department of Dermatology,
University of Münster Germany. “TRuE-V is the first large-scale
clinical trials program in vitiligo and its results clearly
demonstrate the clinically meaningful improvements in facial and
total body repigmentation seen with Opzelura and its potential to
further optimize patient care and outcomes.”
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. Over-activity of the JAK signaling pathway is
believed to drive inflammation involved in the pathogenesis and
progression of vitiligo. In the European Union, EEA countries and
UK diagnosed vitiligo prevalence is estimated to be ~1.5 million
patients2,3, with approximately 8 in 10 patients suffering from
non-segmental vitiligo4, and a subset of whom has facial
involvement and seeking treatment. Vitiligo can occur at any age,
although many patients with vitiligo will experience initial onset
before the age of 305.
“Vitiligo is a chronic autoimmune disease that impacts many
aspects of a person’s life,” said Jean-Marie Meurant,
Vice-President of the Vitiligo International Patient Organizations
Committee (VIPOC). “The arrival of new treatment options are
important for our community as it gives people with vitiligo
something they have long been hoping for: the choice to treat their
disease.”
About Opzelura® (ruxolitinib) Cream 15mg/g 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 European Union (EU), indicated for the treatment of
non-segmental vitiligo with facial involvement in adults and
adolescents from 12 years of age.
In patients with non-segmental vitiligo with facial involvement,
Opzelura is approved for topical use twice daily to the depigmented
skin areas up to a maximum of 10% body surface area. Satisfactory
repigmentation may require treatment with Opzelura for more than 24
weeks.
Opzelura is approved in the U.S. for the topical treatment of
non-segmental vitiligo in patients 12 years of age and older and
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.
Incyte has worldwide rights for the development and
commercialization of 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, 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 whether and when Opzelura
will provide a successful treatment option for patients with
vitiligo, 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 Opzelura® (ruxolitinib) cream
15mg/g. Summary of Product Characteristics (SmPC). Incyte; April
2023. 2 Mohr N, et al. Epidemiology of Vitiligo - A Dual
Population-Based Approach. Clinical Epidemiology. 2021 May 26;
13:373-382. 3 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. 4 Gandhi K, et al. Prevalence of Vitiligo Among Adults
in the United States. JAMA Dermatol. 2022 Jan 1;158(1):43-50. 5
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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