FDA Extends Review Period for Ruxolitinib Cream for Vitiligo

The sNDA submission included data from the phase 3 TRuE-V clinical trial program.

The Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib cream, a topical Janus kinase inhibitor, for the treatment of vitiligo. 

The new Prescription Drug User Fee Act (PDUFA) target date is July 18, 2022. The FDA extended the action date by 3 months to allow time to review additional data from ongoing phase 3 studies.

The FDA had accepted for Priority Review the sNDA for ruxolitinib cream for vitiligo in December 2021. The application included data from the phase 3 TRuE-V1 (ClinicalTrials.gov Identifier: NCT04052425) and TRuE-V2 (ClinicalTrials.gov Identifier: NCT04057573) studies. Each study evaluated the efficacy and safety of a topical formulation of ruxolitinib in approximately 300 patients 12 years of age and older who had been diagnosed with nonsegmental vitiligo and had depigmented areas. 

Results from both studies demonstrated that ruxolitinib met the primary endpoint with a greater proportion of patients achieving at least a 75% improvement from baseline in the Face Vitiligo Area Scoring Index score at week 24 compared with vehicle (P <.0001 for both studies). Key secondary endpoints, including patient reported outcomes, were also met.

“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 MD, Chief Medical Officer, Incyte.

Ruxolitinib cream is marketed under the brand name Opzelura™ and is currently approved for the short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis in nonimmunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.


Incyte announces US FDA has extended the supplemental New Drug Application review period for ruxolitinib cream (Opzelura™) for the treatment of vitiligo. News release. Incyte Corportion. Accessed March 14, 2022. https://www.businesswire.com/news/home/20220314005251/en/Incyte-Announces-U.S.-FDA-Has-Extended-the-Supplemental-New-Drug-Application-Review-Period-for-Ruxolitinib-Cream-Opzelura%E2%84%A2-for-the-Treatment-of-Vitiligo