U.S. FDA Approves Subcutaneous Induction Regimen for AbbVie's SKYRIZI® (risankizumab-rzaa) for Adults With Moderately to Severely Active Crohn's Disease

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  "detected_at": "2026-10-23T19:33:00+00:00",
  "company": {
    "name": "AbbVie",
    "domain": "abbvie.com"
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  "data": {
    "url": "https://www.prnewswire.com/news-releases/us-fda-approves-subcutaneous-induction-regimen-for-abbvies-skyrizi-risankizumab-rzaa-for-adults-with-moderately-to-severely-active-crohns-disease-302918434.html",
    "title": "U.S. FDA Approves Subcutaneous Induction Regimen for AbbVie's SKYRIZI® (risankizumab-rzaa) for Adults With Moderately to Severely Active Crohn's Disease",
    "ticker": "NYSE:ABBV",
    "excerpt": "NORTH CHICAGO, Ill. , Oct. 23, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV ) today announced the U.S. Food and Drug Administration has approved a subcutaneous (SC) induction regimen for SKYRIZI ® (risankizumab-rzaa) for adults with moderately to severely active Crohn's disease (CD) iv . Patients now have the option to start SKYRIZI treatment at home, with induction doses delivered by an on-body injector (OBI) induction pack and then continue using an OBI once every eight weeks throughout the course of maintenance treatment. \"People living with Crohn's disease need treatments that can deliver meaningful disease control from the start,\" said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. \"With the approval of subcutaneous induction, we are building on the strong efficacy of SKYRIZI while giving patients and physicians greater flexibility in how treatment is initiated. This is one more example of how AbbVie continues to advance treatment to better meet the needs of people living with Crohn's disease.\" Subcutaneous SKYRIZI Shows High Rates of Clinical Remission and Endoscopic Response by Week 12 iii This FDA approval is supported by positive results from the Phase 3 AFFIRM trial evaluating the efficacy and safety of SC SKYRIZI versus placebo in patients with moderately to severely active CD. iii SKYRIZI achieved superiority...",
    "product": "SKYRIZI subcutaneous induction regimen",
    "summary": "AbbVie announced that the U.S. FDA approved a subcutaneous induction regimen for SKYRIZI for adults with moderately to severely active Crohn's disease.",
    "location": "North Chicago, Illinois, United States",
    "planning": false,
    "confidence": 0.95,
    "product_data": {
      "name": "SKYRIZI subcutaneous induction regimen",
      "full_text": "subcutaneous (SC) induction regimen for SKYRIZI ® (risankizumab-rzaa)",
      "fuzzy_match": false,
      "release_type": "variant"
    },
    "product_tags": [
      "medical"
    ],
    "published_at": "2026-10-23T19:33:00Z",
    "location_data": [
      {
        "city": "North Chicago",
        "state": "Illinois",
        "region": "Northern America",
        "country": "United States",
        "continent": "Americas",
        "fuzzy_match": false
      }
    ],
    "effective_date": "2026-10-23",
    "article_sentence": "AbbVie (NYSE: ABBV ) today announced the U.S. Food and Drug Administration has approved a subcutaneous (SC) induction regimen for SKYRIZI ® (risankizumab-rzaa) for adults with moderately to severely active Crohn's disease (CD) iv ."
  }
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