FDA Extends Review of AbbVie's Skin Drug Application
April 02 2021 - 5:23PM
Dow Jones News
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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