FDA Approves Second Indication for Skyrizi For Active Psoriatic Arthritis

The FDA has approved AbbVie Inc's ABBV Skyrizi (risankizumab-rzaa) for active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints.

• The FDA approval is supported by data from two pivotal studies, KEEPsAKE-1 and KEEPsAKE-2.
• Across the two Phase 3 studies, Skyrizi met the primary endpoint of ACR20 response at week 24 compared to placebo and demonstrated significant improvements across several other manifestations of PsA, including swollen, tender, and painful joints.
• Related: Europe Approves AbbVie's Skyrizi For Second Indication.
• Skyrizi maintains a dosing regimen for PsA consistent with the existing regimen for moderate to severe plaque psoriasis patients – a single 150 mg subcutaneous injection four times a year (after two starter doses at weeks 0 and 4) – and can be administered alone or in combination with DMARDs.
• Related content: Benzinga's Full FDA Calendar.
• Price Action: ABBV shares closed at $131.98 on Friday.