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FDA approves Novo Nordisk's oral semaglutide for cardiovascular (CV) risk reduction in adults with type 2 diabetes who are at high risk, including those who have not had a prior CV event

  • The FDA has approved Novo Nordisk's oral semaglutide for reducing cardiovascular risk in adults with type 2 diabetes who are at high risk, including those without a prior cardiovascular event.
  • The SOUL trial results support the clinical profile of semaglutide, which has been studied in various therapeutic areas.
  • Adults with type 2 diabetes face a higher risk of cardiovascular events, highlighting the need for therapies that address more than just blood sugar levels.
  • Oral semaglutide demonstrated a 14% relative reduction in risk of major adverse cardiovascular events over four years compared to placebo.
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The Berkshire EagleThe Berkshire Eagle
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FDA approves Novo Nordisk's oral semaglutide for cardiovascular (CV) risk reduction in adults with type 2 diabetes who are at high risk, including those who have not had a prior CV event

Rybelsus® (semaglutide) tablets 7 mg or 14 mg, the only FDA-approved oral GLP-1 medicine available, now indicated to reduce the risk of major adverse cardiovascular events (MACE) such as CV death, heart attack, or stroke in adults with type 2…

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PR Newswire broke the news in United States on Friday, October 17, 2025.
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