AbbVie Says FDA Didn't Meet Action Date for Dermatitis Treatment Application

By Dave Sebastian

AbbVie Inc. said the U.S. Food and Drug Administration didn't meet the Prescription Drug User Fee Act action date for the supplemental new drug application for the company's treatment for moderate to severe atopic dermatitis.

The FDA cited an ongoing review of Pfizer Inc.'s post-marketing study evaluating tofacitinib in patients with rheumatoid arthritis, AbbVie said Friday.

The company said no formal regulatory action has been taken on the applications for the drug, Rinvoq, in atopic dermatitis, psoriatic arthritis or ankylosing spondylitis.

"We remain confident in the strong efficacy data and in the safety profile for Rinvoq," Vice Chairman and President Michael Severino said.

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(END) Dow Jones Newswires

07-16-21 0857ET