FDA approves Opzelura cream as topical atopic dermatitis treatment

The FDA has approved Opzelura cream for the treatment of atopic dermatitis in non-immunocompromised patients, Incyte announced in a press release.

Opzelura (ruxolitinib) cream is the first topical JAK inhibitor approved in the United States. It is indicated for patients aged 12 years and older whose disease is not adequately controlled with other topical prescription products.

“The approval of Opzelura is an important advancement in the treatment of AD, and we are pleased to offer a novel topical treatment option that targets a pathway believed to be a source of inflammation,” Incyte CEO Hervé Hoppenot said in the release. “At Incyte, we are committed to transforming the treatment of immune-mediated dermatologic conditions like AD. We look forward to bringing Opzelura to the patient community and also continuing to explore its potential in other challenging skin diseases.”

The approval was based on data from the TRuE-AD clinical trial program, which included two randomized, double-blind, vehicle-controlled phase 3 studies involving more than 1,200 subjects with mild to moderate AD.

More patients treated with Opzelura — 52.8% in TRuE-AD1 and 51.3% in TRuE-AD2 — achieved clear or almost clear skin after 8 weeks of twice-daily dosing compared with 15.1% in TRuE-AD1 and 7.6% in TRuE-AD2 of vehicle-treated patients.