(RTTNews) - AbbVie (ABBV) said Friday that the U.S. Food and Drug Administration has extended the review period for the supplemental New Drug Application (sNDA) for upadacitinib in the treatment of adults and adolescents with moderate to severe atopic dermatitis.
The Prescription Drug User Fee Act or PDUFA action date has been extended three months to early third-quarter 2021.
AbbVie received an information request from the FDA for an updated assessment of the benefit-risk profile for upadacitinib in atopic dermatitis. AbbVie responded to the request and the FDA has informed AbbVie that it requires additional time for a full review of the submission.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
