AbbVie announced that the U.S. Food and Drug Administration (FDA) 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 (PDUFA) action date has been extended three months to early Q3 2021.
As previously disclosed, 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, as expected, it requires additional time for a full review of the submission.
“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,” said Michael Severino, M.D., vice chairman and president, AbbVie.