On Monday, Novo Nordisk A/S
Last year, Novo Nordisk's subcutaneous once-weekly (injectable) semaglutide 2.4 mg, available as Wegovy, showed a 20% reduction in MACE compared to placebo.
The SOUL trial compared oral semaglutide to placebo as an adjunct to the standard of care to prevent major adverse cardiovascular events (MACE), such as cardiac arrest, stroke, heart failure, or cardiovascular death.
The SOUL trial was initiated in 2019 and enrolled 9,650 people with type 2 diabetes and established cardiovascular disease (CVD) and/or chronic kidney disease (CKD).
Oral semaglutide is administered once daily and is approved for use in three doses, 3 mg, 7 mg, and 14 mg, under the brand name Rybelsus.
It is indicated for adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise.
As part of the standard of care, 49% of patients received SGLT2i at some point during the trial.
The trial achieved its primary objective by demonstrating a statistically significant and superior reduction in MACE of 14% for people treated with oral semaglutide compared to placebo.
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.
All three primary endpoint components contributed to the superior MACE reduction demonstrated by oral semaglutide.
In the trial, oral semaglutide appeared to have a safe and well-tolerated profile in line with previous oral semaglutide trials.
Novo Nordisk expects to file for regulatory approval of a label expansion for Rybelsus in the US and EU around late 2024 or early 2025.
The detailed results from SOUL will be presented at a scientific conference in 2025.
In 2023, Rybelsus generated global revenues of DKK18.75 billion (around $2.73 billion).
Price Action: NVO stock is down 0.41% at $117.60 during the premarket session at last check Monday.
