AbbVie (ABBV) Announces FDA Will Not Meet PDUFA Action Dates for RINVOQ sNDAs

AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has informed the company that the FDA will not meet the Prescription Drug User Fee Act (PDUFA) action dates for the supplemental New Drug Applications (sNDAs) for RINVOQ® (upadacitinib) for the treatment of adults with active psoriatic arthritis and adults with active ankylosing spondylitis. The FDA cited its ongoing review of Pfizer's post-marketing study, ORAL Surveillance, evaluating tofacitinib in patients with rheumatoid arthritis.