Incyte Announces that the U.S. FDA has Extended the Additional New Drug Application Review Period for Ruxolitinib Cream (Opzelura™) for the Treatment of Vitiligo

WILMINGTON, Delaware, March 14, 2022–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) today announced 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) effective date has been extended three months to July 18, 2022.

The FDA has extended the PDUFA action date to allow time to review additional data from ongoing Phase 3 studies submitted by Incyte in response to the FDA’s request for information. The submission of the additional information was determined by the FDA to constitute a major amendment to the sNDA, resulting in an extension of the PDUFA deadline.

“We are confident in the data from the TRuE-V clinical trial program that support 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 which there are no approved therapies that treat repigmentation,” said Steven Stein MD, chief medical officer at 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 over 600 adolescent and adult patients (aged 12 years and older) with non-segmental vitiligo.

About ruxolitinib cream (Opzelura™)

Ruxolitinib cream (Opzelura), a new 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 short-term topical treatment term and chronic non-continuous mild to moderate atopy. dermatitis (AD) in non-immunocompromised patients aged 12 years and over whose disease is not adequately controlled by topical prescription treatments, or when these treatments are not recommended. The use of Opzelura in combination with biological therapeutic agents, other JAK inhibitors or strong immunosuppressants, such as azathioprine or cyclosporine, is not recommended.

On October 28, 2021, Incyte announced approval of the European Marketing Authorization Application (MA) for ruxolitinib cream as a potential treatment for adolescents and adults (age > 12 years) with vitiligo non-segmental 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 to develop and commercialize ruxolitinib cream, marketed in the United States as Opzelura.

Opzelura is a registered trademark of Incyte.

About Incyte

Incyte is a global biopharmaceutical company based in Wilmington, Delaware, focused on finding solutions to serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutic products. For more information about Incyte, please visit and follow @Incyte.

Forward-looking statements

Except for historical information presented herein, 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 United States 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 could cause actual results to differ materially, including unforeseen developments and risks relating to: unforeseen delays; continued research and development and the results of clinical trials that may be 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 vendors and development and discovery operations; determinations made by the FDA; the efficacy or safety of the Company’s products; market acceptance of the Company’s products; 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 intention or obligation to put update these forward-looking statements.

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