FDA extends review period for Rinvoq sNDA

17 March 2021

The US Food and Drug Administration has extended the review period for the supplemental New Drug Application (sNDA) for Rinvoq (upadacitinib) in the treatment of adult patients with active psoriatic arthritis.

The updated Prescription Drug User Fee Act (PDUFA) action date has been extended three months to late second-quarter 2021, explained US pharma major AbbVie (NYSE: ABBV), whose shares were down more than 6% at $104.18 by early afternoon today.

AbbVie recently received an information request from the FDA for an updated assessment of the benefit-risk profile for its upadacitinib in psoriatic arthritis. AbbVie responded to the request and the FDA will require additional time for a full review of the submission.

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