AbbVie Gains FDA Approval For Subcutaneous Induction Of SKYRIZI In Crohn's Disease

AbbVie's SKYRIZI (risankizumab-rzaa) received FDA approval for a subcutaneous induction regimen in adults with moderately to severely active Crohn's disease. The approval follows positive Phase 3 trial results, showing significant clinical remission and endoscopic response in patients. SKYRIZI can now be administered at home using an on-body injector, with induction doses at weeks 0, 2, 4, and 8, followed by maintenance dosing every eight weeks.

AbbVie (ABBV) received FDA approval for an at-home subcutaneous induction regimen for its drug Skyrizi, allowing adults with moderate to severe Crohn’s disease to start treatment at home. The company offers a 2.34% dividend yield with a high payout ratio of 85% and a 3-year dividend growth rate of 5.2%. AbbVie's GF Value™ suggests the stock is modestly overvalued at $222.72 versus the current price of $286.20.

AbbVie received FDA approval for a subcutaneous induction regimen of Skyrizi to treat Crohn's disease. The company's stock closed at $285.64, up 0.16%.

AbbVie's SKYRIZI (risankizumab-rzaa) received FDA approval for a subcutaneous induction regimen in adults with moderately to severely active Crohn's disease. The approval is based on positive Phase 3 AFFIRM trial results, showing superior clinical remission and endoscopic response at week 12 compared to placebo, especially in treatment-naïve patients. The subcutaneous form allows for at-home administration using an on-body injector.

AbbVie (ABBV) received FDA approval for a subcutaneous induction regimen of Skyrizi for Crohn's disease. The regimen involves 720 mg doses at weeks 0, 2, 4, and 8, with maintenance doses every 8 weeks. The approval is based on Phase 3 trial results showing 56% clinical remission vs. 30% for placebo. The FDA also updated prescribing info to remove mandatory TB testing. Skyrizi is approved for several autoimmune diseases.

AbbVie received FDA approval for a subcutaneous induction regimen of Skyrizi for Crohn’s disease, allowing at-home initiation and maintenance. This expands the drug’s existing approvals and supports AbbVie’s immunology portfolio.