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AbbVie seeks FDA approval for subcutaneous SKYRIZI to treat Crohn's disease in adults.

Market News
27 Apr 2026
PRNewsWire
View Source
Bullish
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AbbVie has submitted an application to the FDA for approval of SKYRIZI (risankizumab-rzaa) as a subcutaneous induction treatment for adults with moderately to severely active Crohn's disease. This follows positive Phase 3 AFFIRM study results demonstrating efficacy and safety. If approved, patients will have the option to start treatment with either subcutaneous injections or intravenous infusions, continuing maintenance with subcutaneous dosing every eight weeks. This new option aims to improve convenience and treatment flexibility for Crohn's disease patients, a chronic inflammatory condition affecting about 1 million Americans.

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