AbbVie (ABBV) said Wednesday that the U.S. Food and Drug Administration has extended the review period for the supplemental New Drug Application or sNDA for upadacitinib in the treatment of adult patients with active psoriatic arthritis.
The FDA has extended the updated Prescription Drug User Fee Act (PDUFA) action date by three months to late the second-quarter of 2021.
AbbVie recently received an information request from the FDA for an updated assessment of the benefit-risk profile for upadacitinib in psoriatic arthritis. AbbVie responded to the request and the FDA will require additional time for a full review of the submission.
In addition, AbbVie said it received a similar request from the FDA related to the sNDA for upadacitinib in atopic dermatitis, which is being prepared and will be submitted to the FDA shortly.
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April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.