HQ Team
October 21, 2024: Danish pharmaceutical company, Novo Nordisk’s oral semaglutide drug to treat type 2 diabetes helped reduce heart diseases by 14% compared to a dummy medicine in a trial, according to a statement.
The trial enrolled 9,650 people with type 2 diabetes and having cardiovascular disease and or chronic kidney disease, the company stated.
Forty-nine per cent of the patients were dosed with the experimental drug Rybelsus. It achieved the main goal of the study, which was a reduction in major adverse cardiovascular events (MACE).
“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.
Regulatory approval
“All three components of the primary endpoint contributed to the superior MACE reduction demonstrated by oral semaglutide,” according to the statement.
Martin Holst Lange, executive vice president and head of Development at Novo Nordisk said: “Approximately one in three adults with type 2 diabetes also have cardiovascular disease; therefore, it is crucial to have therapies that can address both conditions.”
Novo Nordisk expects to file for regulatory approval of a label expansion for Rybelsus in both the US and EU by the end of the year.
Novo stated detailed results from the trial will be presented at a scientific conference in 2025.
Safe, well-tolerated profile
In the trial, oral semaglutide appeared to have a safe and well-tolerated profile in line with previous oral semaglutide trials.
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 the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise.
In the EU, a new formulation of 1.5 mg, 4 mg and 9 mg doses of Rybelsus are approved and are bioequivalent to the original formulation of the drug, according to the statement.
About 422 million people worldwide have diabetes, the majority living in low-and middle-income countries, and 1.5 million deaths are directly attributed to diabetes each year.
Both the number of cases and the prevalence of diabetes have been steadily increasing over the past few decades, according to the World Health Organization.
