Posted by Michael Wonder on 15 Sep 2025
EU approval makes Novo Nordisk’s oral semaglutide the first and only oral GLP-1 RA to reduce cardiovascular death, heart attack and stroke
15 September 2025 - This approval is based on results from the SOUL clinical trial, where oral semaglutide (Rybelsus) reduced cardiovascular death, heart attack and stroke by 14% versus placebo, when added to standard of care, in adults with type 2 diabetes at high cardiovascular risk.
Novo Nordisk today announced that the EMA's CHMP has approved an update to the Rybelsus (oral semaglutide) label to reflect the cardiovascular benefits seen in the SOUL trial.
