Research & Development
US FDA extends review period for AbbVie's upadacitinib supplemental New Drug Application
5 April 2021 -

The United States Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for United States-based AbbVie's (NYSE:ABBV) upadacitinib intended for the treatment of adults and adolescents with moderate to severe atopic dermatitis, it was reported on Friday.

Reportedly, the Prescription Drug User Fee Act (PDUFA) action date has been extended to the early third quarter of 2021.

AbbVie had received an information request from the US FDA for an updated evaluation of the benefit-risk profile for the product in atopic dermatitis. The company has responded to the request and the FDA has informed the company that, as expected, it needs additional time for a complete review of the submission. The product is a JAK inhibitor that is being studied in various immune-mediated inflammatory diseases.