Incyte Announces U.S. FDA Has Extended the Supplemental New Drug Application Review Period for Ruxolitinib Cream (Opzelura™) for the Treatment of Vitiligo
March 14 2022 - 8:00AM
Business Wire
Incyte Corporation (Nasdaq:INCY) announced today that the U.S.
Food and Drug Administration (FDA) has extended the review period
for the supplemental New Drug Application (sNDA) for ruxolitinib
cream (Opzelura™) for the treatment of vitiligo. The Prescription
Drug User Fee Act (PDUFA) action date has been extended by three
months to July 18, 2022.
The FDA extended the PDUFA action date to allow time to review
additional data from the ongoing Phase 3 studies submitted by
Incyte in response to the FDA’s information request. The submission
of the additional information has been determined by the FDA to
constitute a Major Amendment to the sNDA, resulting in an extension
of the PDUFA goal date.
“We are confident in the data from the TRuE-V clinical trial
program which supports our sNDA submission for ruxolitinib cream in
vitiligo, and we look forward to bringing this innovative topical
treatment to patients with vitiligo in the United States for whom
there are no approved therapies that address repigmentation,” said
Steven Stein M.D., Chief Medical Officer, Incyte.
The pivotal Phase 3 TRuE-V clinical trial program (TRuE-V1 and
TRuE-V2) is evaluating the safety and efficacy of ruxolitinib cream
versus vehicle in more than 600 adolescent and adult patients (age
12 and older) with non-segmental vitiligo.
About Ruxolitinib Cream (Opzelura™)
Ruxolitinib cream (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 United
States 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.
On October 28, 2021, Incyte announced the validation of the
European Marketing Authorization Application (MAA) for ruxolitinib
cream as a potential treatment for adolescents and adults (age
>12 years) with non-segmental vitiligo with facial involvement.
Additionally, in December 2021, Incyte announced the acceptance and
priority review of the supplemental New Drug Application (sNDA) for
ruxolitinib cream as a potential treatment for adolescents and
adults (age ≥12 years) with vitiligo.
Incyte has worldwide rights for the development and
commercialization of ruxolitinib cream, marketed in the United
States as Opzelura.
Opzelura is a trademark of Incyte.
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 vitiligo or any additional indications,
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 effects of the COVID-19 pandemic and measures to address the
pandemic on the Company’s clinical trials, supply chain, other
third-party providers and development and discovery operations;
determinations made by the FDA; 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 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.
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Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
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