Posted by Michael Wonder on 19 Jul 2021
AbbVie provides update regarding Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis in the U.S.
16 July 2021 - AbbVie today announced the U.S. FDA did not meet the Prescription Drug User Fee Act action date for the supplemental new drug application for Rinvoq (upadacitinib monohydrate) for the treatment of adults and adolescents with moderate to severe atopic dermatitis.
Consistent with the recent update on the PDUFA action dates for Rinvoq in psoriatic arthritis and ankylosing spondylitis, the FDA cited its ongoing review of Pfizer's post-marketing study, ORAL Surveillance, evaluating tofacitinib in patients with rheumatoid arthritis.
