FDA To Miss Action Dates For AbbVie's Upadacitinib Application For Psoriatic Arthritis, Ankylosing Spondylitis

The FDA will not meet action dates for AbbVie Inc's ABBV supplemental marketing applications for Rinvoq (upadacitinib) for active psoriatic arthritis and adults with active ankylosing spondylitis.
The FDA cited its ongoing review of Pfizer Inc's PFE post-marketing study, ORAL Surveillance, evaluating tofacitinib in patients with rheumatoid arthritis.
No formal regulatory action has been taken on AbbVie's applications.
In March, the agency extended the action date to late Q2 2021 for psoriatic arthritis as it required additional time to assess the updated benefit-risk profile submitted by the company.
Separately, European Medicines Agency's CHMP adopted a positive opinion recommending the approval of upadacitinib for the expanded use in adults and adolescents for moderate to severe atopic dermatitis who are candidates for systemic therapy.
Related content: Benzinga's Full FDA Calendar.
Price Action: ABBV shares are down 2.26% at $112.50 during the market trading session on the last check Friday.