Morningstar

Incyte Gets FDA Approval for Dermatitis Cream for Young Children

Provided by Dow Jones Sep 18, 2025, 8:51:00 PM

By Dean Seal

Incyte said federal regulators have granted approval for its Opzelura cream to be used as a treatment for certain children aged two years and older with mild to moderate atopic dermatitis.

The biopharmaceutical company said Thursday that the Food and Drug Administration's approval comes after Phase 3 trial data showed treatment with Opzelura resulted in significant efficacy with no new safety concerns.

This is the third U.S. approval for Opzelura, having been previously authorized for chronic treatment of mild to moderate atopic dermatitis in patients aged 12 and up, as well as the treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

September 18, 2025 16:51 ET (20:51 GMT)

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