FDA Approves Label Expansion of BAYRY's Kidney Disease Drug Kerendia

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  "signal_type": "news",
  "signal_subtype": "launches",
  "detected_at": "2026-09-17T14:12:00+00:00",
  "company": {
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    "domain": "bayer.com"
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  "data": {
    "url": "https://www.theglobeandmail.com/investing/markets/stocks/JNJ-N/pressreleases/4659485/fda-approves-label-expansion-of-bayry-s-kidney-disease-drug-kerendia/",
    "title": "FDA Approves Label Expansion of BAYRY's Kidney Disease Drug Kerendia - The Globe and Mail",
    "excerpt": "Bayer BAYRY announced that the FDA has approved a label expansion for kidney disease drug Kerendia (finerenone) for the treatment of adult patients with chronic kidney disease (CKD) associated with type one diabetes (T1D). The drug is a selective, non-steroidal mineralocorticoid receptor antagonist. In the United States, Kerendia was initially approved in 2021 to treat adults with CKD associated with type 2 diabetes (T2D). The drug’s label was expanded in 2025 to include the treatment of adults with symptomatic chronic heart failure with a left ventricular ejection fraction (LVEF) of at least 40%. With the latest approval, Kerendia is now also indicated for adults with CKD associated with T1D. The FDA approval of Kerendia’s expanded indication addresses an important unmet need, as approximately 30% of people with type 1 diabetes in the United States develop CKD, putting them at increased risk of kidney failure. The approval follows the FDA’s Priority Review designation and is supported by positive results from the pivotal phase III FINE-ONE study. In the trial, Kerendia, when added to standard of care, demonstrated a statistically significant 25% reduction from baseline in the urine albumin-to-creatinine ratio (UACR) over six months compared with placebo in adults with CKD associated with T1D. The expanded indication broadens Kerendia’s addressable patient population and...",
    "product": "Kerendia",
    "summary": "The FDA has approved a label expansion for Bayer's kidney disease drug Kerendia, now indicated for the treatment of adult patients with chronic kidney disease (CKD) associated with type one diabetes (T1D).",
    "location": "United States",
    "planning": false,
    "image_url": "https://www.theglobeandmail.com/pf/resources/assets/meta/twitter-summary-240x240.png?d=958",
    "confidence": 0.95,
    "product_data": {
      "name": "Kerendia",
      "full_text": "kidney disease drug Kerendia (finerenone)",
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      "release_type": "update"
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      "medical",
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    "published_at": "2026-09-17T14:12:00Z",
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        "region": "Northern America",
        "country": "United States",
        "continent": "Americas",
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    ],
    "article_sentence": "Bayer BAYRY announced that the FDA has approved a label expansion for kidney disease drug Kerendia (finerenone) for the treatment of adult patients with chronic kidney disease (CKD) associated with type one diabetes (T1D)."
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