Incyte Says FDA Extended Review Period for Opzelura

Published: 2025-06-20 17:26:08 ET INCY

Published on 06/20/2025 at 17:26

By Dean Seal

Incyte said federal regulators have extended the review period for evaluating its Opzelura cream as a treatment for moderate atopic dermatitis in children aged 2 to 11.

The biopharmaceutical company said Friday that the U.S. Food and Drug Administration has extended the review period by three months to Sept. 19, giving it more time to review additional chemistry, manufacturing and controls data from Incyte's recent response to an FDA information request.

"We will continue to work closely with the FDA to ensure the agency has all of the information needed to complete its review," said Steven Stein, Incyte's chief medical officer.

Incyte's Opzelura has already been approved as a topical treatment for nonsegmental vitiligo in patients aged 12 and older in the U.S.

Write to Dean Seal at [email protected]

(END) Dow Jones Newswires

06-20-25 1725ET