- Opzelura® is the first approved treatment in the United Kingdom
(UK) to address repigmentation in non-segmental vitiligo
- Phase 3 data supporting the approval show treatment with
ruxolitinib cream resulted in improved facial and total body
repigmentation, sustained and continued improvements with longer
duration of treatment
- Vitiligo affects around 1 in 100 people in the UK
Incyte Biosciences UK today announced that the Medicines and
Healthcare Products Regulatory Agency (MHRA) has granted marketing
authorisation 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 United Kingdom (UK) to offer
eligible patients with non-segmental vitiligo support for
repigmentation. The MHRA decision follows the European Commission
approval1 earlier in April.
“Today’s MHRA approval is welcome news for dermatologists and
people with vitiligo seeking treatment who until now have had
limited options. The data supporting this approval demonstrate the
potential for ruxolitinib cream to make a difference in the lives
of people living with this condition,” said Dr. Viktoria
Eleftheriadou, Consultant Dermatologist & Lead for Vitiligo
Clinic and Research, Walsall Healthcare NHS Trust and The Royal
Wolverhampton NHS Trust.
Vitiligo is a chronic autoimmune disease in which areas of skin
depigment or lose their colour due the progressive destruction of
pigment-producing cells known as melanocytes2. Around 1 in 100
people in the UK develop vitiligo3,4 with approximately 8 in 10
patients suffering from non-segmental vitiligo, where both sides of
the body are affected by symmetrical white patches5. Vitiligo can
occur at any age, although many patients with vitiligo will
experience initial onset before the age of 304, and have a
significant impact on people living with the condition6.
“While more and more people are proud of their vitiligo, there
are still so many people who don’t feel comfortable in their skin,”
said Emma Rush, Founder and Chief Executive Officer, Vitiligo
Support UK. “This new treatment option provides a choice for those
who wish to treat their condition.”
The MHRA 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 ruxolitinib cream versus
vehicle (non-medicated cream) in more than 600 people with
non-segmental vitiligo, age 12 and older7. Results from the TRuE-V
program 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 and in an open-label
extension at Week 527.
Results at Week 24, which were consistent across both studies,
showed that 29.8% and 30.9% of patients treated with ruxolitinib
cream 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, respectively7. At Week 52, approximately one
in two of ruxolitinib cream-treated patients achieved F-VASI757.
Additionally, at Week 52, approximately one in three of ruxolitinib
cream-treated patients achieved ≥90% improvement from baseline in
F-VASI (F-VASI90)7.
There were no serious treatment-related adverse events related
to ruxolitinib cream and the most common adverse reaction was
application site acne7.
For additional information, please consult the full Summary of
Product Characteristics.
“We are delighted to announce the MHRA approval of Opzelura for
people living with non-segmental vitiligo with facial involvement,”
said Peter Williams, General Manager, Incyte United Kingdom and
Ireland. “We are now working in partnership with the NHS to ensure
that eligible patients seeking to treat their vitiligo are able to
access this innovative medicine.”
”A new treatment specifically approved for vitiligo in the UK is
a significant milestone and furthers our goal at The Vitiligo
Society to support, inspire and educate people about vitiligo,”
said John Dunster, Chairperson, The Vitiligo Society.
About Opzelura® (ruxolitinib) Cream 15mg/g
Ruxolitinib cream, a novel formulation of Incyte’s selective
JAK1/JAK2 inhibitor ruxolitinib, is the first and only topical JAK
inhibitor approved for use in the UK indicated for the treatment of
non-segmental vitiligo with facial involvement in adults and
adolescents from 12 years of age7.
In eligible patients, ruxolitinib cream is approved for topical
use twice daily to the depigmented skin areas up to a maximum of
10% body surface area7. Satisfactory repigmentation may require
treatment with ruxolitinib cream for more than 24 weeks7.
Ruxolitinib cream is approved in the European Union for the
treatment of non-segmental vitiligo with facial involvement in
adults and adolescents from 12 years of age.
In the United States, ruxolitinib cream is approved for the
topical treatment of non-segmental vitiligo in patients 12 years of
age and older. Ruxolitinib cream 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 ruxolitinib cream 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
commercialisation of ruxolitinib cream, marketed in the United
States and Europe as Opzelura.
Opzelura and the Opzelura logo are registered trademarks 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 commercialisation 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; determinations made by the MHRA, 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; the acceptance of
the Company’s products 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 and
subsequent quarterly reports. The Company disclaims any intent or
obligation to update these forward-looking statements.
1 Incyte. (2023, April 20). Incyte Announces European Commission
Approval Of Opzelura® (Ruxolitinib) Cream For The Treatment Of
Non-Segmental Vitiligo With Facial Involvement In Adults And
Adolescents [Press release]
https://investor.incyte.com/news-releases/news-release-details/incyte-announces-european-commission-approval-opzelurar
2 Frisoli M, et al. Vitiligo: mechanisms of pathogenesis and
treatment. Annual. Review of Immunology. 2020; 38(1):621-648. 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 Mohr N, et al. Epidemiology of Vitiligo - A Dual Population-Based
Approach. Clinical Epidemiology. 2021 May 26; 13:373-382. 5 Gandhi
K, et al. Prevalence of Vitiligo Among Adults in the United States.
JAMA Dermatol. 2022 Jan 1;158(1):43-50. 6 Bibeau K, et al. Maui
Derm for Dermatologists 2022. ePoster on Diagnosis and Management
of Vitiligo From the Perspectives of Patients and Healthcare
Professionals: Findings From the Global VALIANT Study. 7 Opzelura®
(ruxolitinib) cream 15mg/g. UK Summary of Product Characteristics.
Incyte; July 2023.
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version on businesswire.com: https://www.businesswire.com/news/home/20230705273477/en/
Media Ela Zawislak +41 21 343 3113 ezawislak@incyte.com
Lottie Williams, Curious Health +44 7972 151 7972
lottie@curioushealth.io Investors Greg Shertzer +1 302 274
4779 gshertzer@incyte.com
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