European Medicines Agency Set to Review Incyte’s Ruxolitinib Cream in Vitiligo
Ruxolitinib cream is an investigational novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitini
The European Medicines Agency validated the European Marketing Authorization for Incyte’s ruxolitinib cream as a potential treatment for adolescents and adults (age >12 years) with non-segmental vitiligo with facial involvement.
The validation of the Marketing Authorization Application (MAA) by the European Medicines Agency confirms that the submission is ready to enter the formal review process.
Ruxolitinib cream is an investigational novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib. In September 2021, ruxolitinib cream (Opzelura™) was approved for use by the U.S. Food and Drug Administration (FDA) 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.
“The EMA’s validation of the MAA for ruxolitinib cream marks an important milestone for people with vitiligo, for whom there is often a significant impact on everyday life and who currently have limited treatment options,” says Jonathan Dickinson, General Manager Europe, Executive Vice President at Incyte, in a news release. “We are committed to listening to the patient community to understand how we can help fulfill unmet needs and support healthcare providers to better manage this challenging disease. We look forward to working with the regulatory authorities, with the aim to bring this new potential therapy to eligible patients as soon as possible.”
The MAA is supported by data from the Phase 3 TRuE-V clinical trial program evaluating the safety and efficacy of ruxolitinib cream in more than 600 people (age >12 years) with vitiligo. Results from the Phase 3 program, recently presented at the 30th European Academy of Dermatology and Venereology (EADV) congress during a late-breaking research session, showed significant improvements in facial and total body repigmentation at 24 weeks of treatment with ruxolitinib cream in people with vitiligo. In the TRuE-V studies, patients using ruxolitinib cream did not report clinically significant application site reactions, and the overall safety profile was consistent with previous study data.
More on TRuE-V
The TRuE-V clinical trial program includes two Phase 3 studies, TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573), evaluating the safety and efficacy of ruxolitinib cream in patients with vitiligo.
The studies each enrolled approximately 300 patients (age ≥12 years) who have been diagnosed with non-segmental vitiligo and have depigmented areas including at least 0.5% of the body surface area (BSA) on the face, ≥0.5 facial vitiligo area severity index [F-VASI] score, at least 3% BSA on nonfacial areas, ≥3 total body Vitiligo Area Scoring Index [T-VASI] score and total BSA involvement (facial and nonfacial) of up to 10%. Participants were randomized into two arms: 1.5% ruxolitinib cream twice daily (BID) and vehicle control for the 24-week double-blind period. Patients who successfully completed baseline and Week 24 assessments, including those that received vehicle control during the double-blind phase, were offered treatment extension with 1.5% ruxolitinib cream BID for an additional 28 weeks.
The primary endpoint of both studies in the TRuE-V program is the proportion of patients achieving F-VASI75, defined as at least a 75% improvement from baseline in the F-VASI score at Week 24. Key secondary endpoints include: the percentage change from baseline in facial BSA (F-BSA) at Week 24, the proportion of patients achieving F-VASI50 (at least 50% improvement from baseline in the F-VASI), F-VASI90 (at least 90% improvement from baseline in the F-VASI) and T-VASI50 (at least 50% improvement from baseline in the T-VASI) at Week 24, the proportion of patients achieving F-VASI75, F-VASI90, T-VASI50 and T-VASI75 (at least 75% improvement from baseline in the T-VASI) at Week 52 and the proportion of patients achieving a Vitiligo Noticeability Scale (VNS) score of 4 (a lot less noticeable) or 5 (no longer noticeable) at Week 24. The studies also track the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream.