- 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.
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