Posted by Michael Wonder on 26 Jun 2021
AbbVie provides update regarding Rinvoq (upadacitinib) in psoriatic arthritis and ankylosing spondylitis in the U.S.
25 June 2021 - AbbVie today announced that the U.S. FDA has informed the company that the FDA will not meet the Prescription Drug User Fee Act action dates for the supplemental new drug applications for Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis and adults with active ankylosing spondylitis.
The FDA cited its on-going review of Pfizer's post-marketing study, ORAL Surveillance, evaluating tofacitinib in patients with rheumatoid arthritis.
No formal regulatory action has been taken on the supplemental new drug applications for Rinvoq in psoriatic arthritis and ankylosing spondylitis.
