The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application for ruxolitinib cream, a topical Janus kinase inhibitor, for the treatment of patients 12 years of age and older with vitiligo.
The application is supported by data from the phase 3 TRuE-V clinical trial program, which includes 2 randomized, double-blind, vehicle-controlled studies: TRuE-V1 (ClinicalTrials.gov Identifier: NCT04052425) and TRuE-V2 (ClinicalTrials.gov Identifier: NCT04057573). Each study evaluated the efficacy and safety of a topical formulation of ruxolitinib in approximately 300 patients 12 years of age and older who have been diagnosed with nonsegmental vitiligo and have depigmented areas. Patients were randomly assigned 1:1 to receive ruxolitinib 1.5% cream twice daily or vehicle for 24 weeks.
Results from both studies showed that 29.9% of patients treated with ruxolitinib achieved at least 75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75) at week 24 (primary endpoint).
Improvements were also observed for key secondary endpoints; more than 51% of patients treated with ruxolitinib achieved at least 50% improvement from baseline in F-VASI, and more than 15% achieved at least 90% improvement from baseline in F-VASI. Additionally, a significantly greater proportion of patients in the ruxolitinib treatment arm achieved at least 50% improvement from baseline in total body Vitiligo Area Scoring Index and a Vitiligo Noticeability Scale response compared with vehicle.
“Currently, there are no FDA-approved drug therapies for repigmentation in people with vitiligo,” said Jim Lee, MD, PhD, Group Vice President, Inflammation & Autoimmunity, Incyte. “The FDA’s acceptance of our sNDA for ruxolitinib cream brings us one step closer to offering patients with vitiligo an additional treatment option.”
A Prescription Drug User Fee Act (PDUFA) target date of April 18, 2022 has been set for the application.
Ruxolitinib cream is currently marketed under the brand name Opzelura 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 acceptance and Priority Review of sNDA for ruxolitinib cream (Opzelura™) as a treatment for patients with vitiligo. News release. Incyte Corporation. Accessed December 15, 2021. https://www.businesswire.com/news/home/20211214006227/en/Incyte-Announces-Acceptance-and-Priority-Review-of-sNDA-for-Ruxolitinib-Cream-Opzelura%E2%84%A2-as-a-Treatment-for-Patients-with-Vitiligo.
- Incyte announces full results from phase 3 TRuE-V program evaluating ruxolitinib cream (Opzelura™) in patients with vitiligo. News release. Incyte Corporation. October 2, 2021. Accessed December 15, 2021. https://investor.incyte.com/press-releases/press-releases/2021/Incyte-Announces-Full-Results-From-Phase-3-TRuE-V-Program-Evaluating-Ruxolitinib-Cream-Opzelura-in-Patients-With-Vitiligo/.