Incyte noted that the latest move comes after the acceptance and priority review of its sNDA for the cream in December last year.
The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date to 18 July this year.
The extension will allow review of additional data submitted by Incyte from the ongoing Phase III studies in response to the FDA’s information requests.
This additional information submission has been determined by the regulatory to constitute a major amendment to the sNDA.
Incyte chief medical officer Steven Stein said: “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.”
Ruxolitinib is a new cream formulation of the company’s selective JAK1/JAK2 inhibitor ruxolitinib, which is claimed to be the first and only topical JAK inhibitor approved in the US to treat mild to moderate atopic dermatitis (AD) patients aged 12 years and above.
The Phase III TRuE-V clinical trial programme (TRuE-V1 and TRuE-V2) is designed to assess ruxolitinib cream’s efficacy and safety in over 600 non-segmental vitiligo adolescent and adult patients aged 12 and above.
The company has announced the European Marketing Authorization Application’s (MAA) validation for ruxolitinib cream for the same indication in October last year.