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 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.