FDA Extends Review of AbbVie's Skin Drug Application

   By Kimberly Chin

AbbVie Inc. said Friday that the U.S. Food and Drug Administration has extended the review of its supplemental new drug application for its skin drug upadacitinib by three months.

The Prescription Drug Fee Act action date for that treatment for adults and adolescents with moderate to severe atopic dermatitis has been extended to early in the third quarter, the company said.

AbbVie received an information request from the agency asking for an updated assessment of the benefit-risk profile for the drug and the company responded, it said. Following the response, the FDA required more time to fully review the submission, AbbVie said.

"We are confident in the sNDA and continue to work with the FDA to bring upadacitinib to patients living with moderate to severe atopic dermatitis in need of new treatment options," AbbVie's Vice Chairman and President Michael Severino said in prepared remarks.

Write to Kimberly Chin at kimberly.chin@wsj.com

(END) Dow Jones Newswires

April 02, 2021 18:08 ET (22:08 GMT)

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