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Dr. Rosmarin details the TruE-V clinical trial, and speaks to what could eventually be the first FDA approved medicine for vitiligo.
Recently, pharmaceutical company Incyte announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for ruxolitinib cream 1.5% (Opzelura) for Priority Review.
Ruxolitinib is a topical Janus-kinase (JAK) inhibitor with potential for treatment for adolescents (12 years old) and adults with vitiligo, a skin condition that affects over 1.5 million people globally. Half of all cases of vitiligo are childhood onset.
The Prescription Drug User Fee Act (PDUFA) target action date is April 18, 2022.
Previous indication for the topical cream was reported on in late September of this year, when the FDA approved ruxolitinib for mild-to-moderate atopic dermatitis in patients 12 years and older.
The newest data for ruxolitinib come from phase 3 of the TruE-V clinical trial, which evaluated the safety and efficacy of the cream in over 600 patients 12 years and older with non-segmental vitiligo. Results from the trial were presented at the 30th European Academy of Dermatology and Venereology (EADV) congress.
In an interview with HCPLive, David Rosmarin, MD, Vice Chair of Research and Education, Dermatology Department at Tufts Medical Center, spoke about the trial data as well as the potential ruxolitinib has for the treatment of vitiligo.
“(The data are) particularly important because we don't have a single medicine (for vitiligo) that's FDA approved,” Rosmarin said. “Oftentimes, our standard treatments now are corticosteroids or calcium learning inhibitors, which are insufficient in many patients.”
The 24-week TruE-V clinical trial offered promising results in patients who were treated twice-daily with ruxolitinib.
Facial and total body repigmentation were observed in the trial. At week 24, the data showed that 29.9% of patients who applied ruxolitinib cream achieved ≥75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), which met the primary endpoint of the study.
Though results from the phase 3 trial were positive, Rosmarin cited his interest in future studies of ruxolitinib, which would likely incorporate a more diverse patient population and a longer trial period, among other differences.
“So far, we only have the primary and key secondary endpoints, which have all been positive,” Rosmarin said. “However, we still have to do different subgroup analyses to see are there differences based on ages, on race, on the amount of vitiligo that patients have, to try to figure out more about how we can benefit patients most with this option. So that's to come.”
To hear more from Dr. Rosmarin, watch the interview above.