Novo Nordisk (NVO) said Monday the European Medicines Agency's Committee for Medicinal Products for Human Use approved an update to the label for its oral diabetes drug Rybelsus to include cardiovascular effects.

The company said the decision was based on results from the phase 3b Soul trial, which indicated that Rybelsus lowered the combined risk of cardiovascular death, heart attack and stroke by 14% compared with placebo in adults with type 2 diabetes at high cardiovascular risk.

Novo Nordisk said a US decision on extending Rybelsus's label for cardiovascular use is expected later this year, while regulators are also reviewing an application for a 25 mg oral semaglutide formulation for obesity and heart disease, marketed as Wegovy in other forms.