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July 19, 2022
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FDA approves Opzelura cream for vitiligo

Fact checked byKristen Dowd
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The FDA has approved the topical Janus kinase inhibitor Opzelura for the treatment of nonsegmental vitiligo in adolescents and adults, Incyte announced in a press release.

Perspective from John E Harris, MD, PhD

Opzelura (ruxolitinib) cream 1.5% is the first FDA-approved treatment for repigmentation in patients with vitiligo.

Vitiligo Woman
The FDA has approved the topical Janus kinase inhibitor Opzelura for the repigmentation of nonsegmental vitiligo.

“This is the start of offering some hope and options to patients who want to be repigmented and hopefully give them the chance to do that,” David Rosmarin, MD, dermatologist and vice chair of research and education for the department of dermatology at Tufts Medical Center and a lead investigator of the ruxolitinib trials, told Healio.

David Rosmarin

The approval was based on data from two phase 3 TRuE-V clinical trials, which included more than 600 people with nonsegmental vitiligo.

At week 24, approximately 30% of patients treated with Opzelura had at least a 75% improvement in facial Vitiligo Area Scoring Index (F-VASI75), compared with approximately 8% and 13% of those in the vehicle arms.

At week 52, approximately 50% of patients achieved F-VASI75 and about 30% achieved F-VASI90.

“It’s important to know that repigmentation takes time. Some patients respond early, some may take a little more time. But the longer you use the medicine, the more benefits the patient will get,” Rosmarin said. “When we look at different subgroups ... all the patients seem to have a consistent response.”

The drug’s side effects included mild acne and application site reaction.

“With the approval of Opzelura in nonsegmental vitiligo, Incyte has once again delivered a treatment to patients with high unmet medical need who previously had no approved therapies,” Hervé Hoppenot, Incyte CEO, said in the release. “We are proud of Incyte’s scientists and development teams that have made this milestone possible, and we're pleased that eligible vitiligo patients now have a choice to address repigmentation.”

Opzelura was previously approved for the short-term, noncontinuous treatment of mild to moderate dermatitis.