Ruxolitinib Cream Receives Priority Review

Incyte announced that the FDA has accepted for Priority Review its supplemental New Drug Application (sNDA) for ruxolitinib cream 1.5% (Opzelura; Incyte) as a possible treatment for patients 12 years and older with vitiligo.¹ If approved, ruxolitinib cream would be the first topical Janus kinase (JAK) inhibitor available in the United States to treat this skin condition. 

The FDA grants Priority Review to medications that may offer a major advance in treatment where none currently exists. The Prescription Drug User Fee Act (PDUFA) target action date is April 18, 2022.

“Vitiligo is a chronic autoimmune disease that can have a profound impact on people’s lives,” said Jim Lee, MD, PhD, group vice president of inflammation & autoimmunity at Incyte in Wilmington, Delaware. “Currently, there are no FDA-approved drug therapies for repigmentation in people with vitiligo. The FDA’s acceptance of our sNDA for ruxolitinib cream brings us one step closer to offering patients with vitiligo an additional treatment option.”

The sNDA is supported by data from the phase 3 TRuE-V clinical trial program which includes TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573). The trials investigated the safety and efficacy of ruxolitinib as a treatment in more than 600 patients 12 years and older with nonsegmental vitiligo.

Findings from the week 24 analysis showed treatment with 1.5% ruxolitinib cream twice daily (BID) resulted in greater improvement to vehicle for the primary and all key secondary endpoints in both the TRuE-V1 and TRuE-V2 studies, our previous reporting showed.²

Results, which were consistent across both studies, showed:

• 29.9% of patients applying ruxolitinib cream achieved greater than or equal to 75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75) at week 24, which was the primary endpoint.
• More than 51% of patients from baseline who were in the ruxolitinib treatment arm achieved F-VASI50, and more than 15% of patients applying ruxolitinib cream achieved F-VASI90, which were key secondary endpoints.
• Additional key secondary endpoints were met, including a significantly higher proportion of patients achieving greater than or equal to 50% improvement from baseline in total body Vitiligo Area Scoring Index (T-VASI50) and a Vitiligo Noticeability Scale (VNS) response with application of ruxolitinib cream compared to vehicle. Study data also uncovered a significant improvement in the percentage change from baseline in facial body surface area (F-BSA) with application of ruxolitinib cream compared to vehicle.

In September 2021, the FDA approved ruxolitinib cream for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

Reference:

1. Incyte announces acceptance and priority review of snda for ruxolitinib cream (Opzelura) as a treatment for patients with vitiligo. Incyte. Accessed December 15, 2021. https://investor.incyte.com/press-releases/press-releases/2021/Incyte-Announces-Acceptance-and-Priority-Review-of-sNDA-for-Ruxolitinib-Cream-Opzelura-as-a-Treatment-for-Patients-with-Vitiligo/default.aspx

2. Incyte announces full results from phase 3 true-v program evaluating ruxolitinib cream (Opzelura) in patients with vitiligo. Incyte. Press release. Published October 2, 2021. Accessed November 11, 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/default.aspx