Incyte Announces U.S. FDA Has Extended the Supplemental New Drug Application Review Period for Ruxolitinib Cream (Opzelura™) for the Treatment of Vitiligo
The FDA extended the PDUFA action date to allow time to review additional data from the ongoing Phase 3 studies submitted by
“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 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
On
Opzelura is a trademark of
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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
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
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