AbbVie Says FDA Didn't Meet Action Date for Dermatitis Treatment Application
July 16 2021 - 9:09AM
Dow Jones News
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.
Write to Dave Sebastian at dave.sebastian@wsj.com
(END) Dow Jones Newswires
July 16, 2021 08:57 ET (12:57 GMT)
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