FDA approval

New Treatment Milestone: FDA Approves Subcutaneous Induction Regimen for Skyrizi

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A New Step Forward for Ulcerative Colitis Treatment

The landscape of treatment for adults living with moderately to severely active ulcerative colitis (UC) has officially expanded. The FDA has approved a new subcutaneous induction regimen for AbbVie’s Skyrizi (risankizumab-rzaa), providing patients with a new, flexible option for managing their condition.

What This Approval Means

Previously, Skyrizi was approved as an intravenous (IV) induction treatment followed by subcutaneous maintenance. This new approval allows for a subcutaneous induction regimen, which may offer greater convenience for patients starting their journey on this therapy. By targeting the IL-23 protein, Skyrizi aims to help patients achieve clinical remission and endoscopic improvement.

Key Highlights of the Update

  • Expanded Administration: Patients can now utilize a subcutaneous route for the induction phase of their treatment.
  • Targeted Therapy: Skyrizi remains the first and only IL-23 inhibitor approved for ulcerative colitis.
  • Focus on Remission: The therapy is designed to help patients reach clinical, endoscopic, and histologic remission.

Looking Ahead

This approval marks a significant development for the UC community, offering an additional pathway for those who have not responded well to, or who cannot tolerate, conventional therapies. As always, patients should consult with their healthcare providers to determine if this new regimen is the right fit for their specific health needs.

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