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

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.
Posted In: ArthritisBriefsBiotechNewsHealth CareFDAGeneral