Novo Nordisk plans to file a label expansion for Rybelsus (oral semaglutide) as an adjunct treatment for the prevention of major adverse cardiovascular events (MACE) in patients with type 2 diabetes (T2D) and established cardiovascular disease (CVD) and/or chronic kidney disease (CKD).
The Phase III SOUL trial (NCT03914326) met its primary endpoint by reducing the occurrence of MACE by 14% with Rybelsus compared to placebo. The study defined the composite outcome of the first occurrence of MACE as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.
Novo Nordisk intends to file for regulatory approval for Rybelsus label expansion in the indication in the US and Europe in late 2024/early 2025. The US Food and Drug Administration (FDA) approved the once-daily pill as a treatment for T2D in 2019.
If approved, Rybelsus will be the second semaglutide medication by Novo Nordisk authorised in the cardiovascular setting. In March, the FDA approved an injectable formulation of semaglutide, Wegovy, for the reduction in the risk of cardiovascular death, heart attack, and stroke in adults with heart disease who are diagnosed as obese or overweight.
The diabetes and obesity segment generated DKr215bn ($31.2bn) in sales for Novo Nordisk, as per the company’s financials. Rybelsus contributed DKr18.7bn ($2.1bn) in sales last year and GlobalData expects the therapy’s sales to exceed $6.8bn in 2030.
GlobalData is the parent company of Clinical Trials Arena.
The Phase III SOUL trial enrolled 9,650 patients with T2D and established CVD and/or CKD. The participants received either Rybelsus or a placebo in addition to the standard of care, including sodium-glucose cotransporter-2 inhibitors (SGLT2i) with which 49% of the participants were treated. Novo Nordisk plans to present full detailed results from the trial at a scientific conference next year.
Novo Nordisk’s competitor Eli Lilly is also looking to expand the label for its diabetes and obesity therapies. In August, Lilly presented data showing that its triple GLP-1/GIP/glucagon receptor agonist, retatrutide, improved cardiac outlook and reduced serum lipids in obese or overweight patients.
