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# FDA Updates Rybelsus Label for CV Risk Reduction
- URL: https://www.fdaweb.com/fda-updates-rybelsus-label-for-cv-risk-reduction/
- Published: 2025-10-20T12:00:00.000Z
- Updated: 2026-09-14T15:24:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160071

FDA has approved a new indication for Novo Nordisk’s Rybelsus (oral semaglutide) tablets to reduce the risk of major adverse cardiovascular events (MACE) — including cardiovascular death, heart attack, or stroke — in adults with Type 2 diabetes who are at high risk for such events, with or without a prior cardiovascular history. The approval makes Rybelsus the first and only oral GLP-1 receptor agonist approved for cardiovascular risk reduction, expanding its use beyond glycemic control, according to the company.

The decision was supported by results from the Phase 3b SOUL trial, which enrolled 9,650 adults with Type 2 diabetes at high cardiovascular risk. Participants who received oral semaglutide 14 mg in addition to standard care experienced a 14% relative reduction in MACE risk compared with placebo. Over four years, 12% of patients in the semaglutide arm experienced a MACE event versus 13.8% in the placebo group, the company says.