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# Novo Nordisk to Seek Rybelsus Expanded Label
- URL: https://www.fdaweb.com/novo-nordisk-to-seek-rybelsus-expanded-label/
- Published: 2024-10-21T12:00:00.000Z
- Updated: 2026-09-14T14:44:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158018

Novo Nordisk says it will seek an expanded label for its diabetes drug Rybelsus (semaglutide) based on data from the SOUL cardiovascular outcomes trial. The double-blind, randomized trial compared oral semaglutide to placebo as an adjunct to standard of care for preventing major adverse cardiovascular events (MACE), according to the company. The trial enrolled 9,650 people with Type 2 diabetes and established cardiovascular disease and/or chronic kidney disease. As part of the standard of care, 49% of patients received a sodium-glucose cotransporter-2 inhibitors at some point during the trial, it says.

The trial showed that semaglutide-treated patients had a statistically significant and superior reduction in MACE of 14% compared to those taking a placebo, Novo Nordick says. “The primary endpoint of the study was defined as the composite outcome of the first occurrence of MACE defined as cardiovascular death, non-fatal myocardial infarction or non-fatal stroke,” it says.

The trial also showed that semaglutide has a safe and well-tolerated profile that is consistent with previous oral semaglutide trials, it adds.