SPY417.26+1.39 0.33%
DIA341.86+1.53 0.45%
IXIC14,052.34+13.58 0.10%

AbbVie Shares Drop As Review For Upadacitinib US Application In Psoriatic Arthritis Pushed Back For Three Months

The FDA has extended the review period AbbVie Inc's (NYSE: 

· 03/17/2021 09:41

The FDA has extended the review period AbbVie Inc's (NYSE: ABBV) supplemental marketing application for upadacitinib to treat adult patients with active psoriatic arthritis.

  • The updated action date has been extended three months to late Q2 2021.
  • AbbVie was recently asked to submit an updated assessment of the benefit-risk profile for upadacitinib in psoriatic arthritis. 
  • The FDA said it would require additional time for a full review of the submission.
  • Separately, AbbVie received a similar request from the FDA related to the upadacitinib application in atopic dermatitis, which is being prepared and submitted to the FDA shortly.
  • This year, the European Commission approved Rinvoq (upadacitinib, 15 mg) for active psoriatic arthritis and active ankylosing spondylitis.
  • Price Action: ABBV shares dropped 6.6% at $103.6 on the last check Wednesday.