Novo Nordisk has received the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) approval for the Rybelsus (oral semaglutide) label update.
The label will now reflect the cardiovascular benefits that are observed in the SOUL clinical study.
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With the approval, Rybelsus becomes the first oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) in the EU with proven cardiovascular benefits.
The decision follows findings from the Phase IIIb SOUL study, in which Rybelsus resulted in a 14% reduction in major adverse cardiovascular events in adults with type 2 diabetes (T2D) at high cardiovascular risk.
The adverse events include cardiovascular death, heart attack, and stroke.
SOUL assessed the cardiovascular outcomes of oral semaglutide in 9,650 patients with T2D with established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD).
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By GlobalDataNovo Nordisk international operations executive vice-president Emil Kongshøj Larsen said: “Heart problems are the leading cause of disability and death for people living with T2D.
“Therefore, treatments that also address heart problems are key to improving not only health outcomes, but also quality of life – and this approval will help do just that.
“This milestone makes semaglutide the only oral GLP-1 RA with proven blood glucose and body weight reduction, as well as cardiovascular benefits.”
Launched in 2019, Rybelsus is available in 48 countries and is used by more than 2.4 million people for T2D management.
It is backed by evidence in reducing blood glucose and body weight compared to other treatments.
Novo Nordisk is expecting a decision on a similar label extension for Rybelsus in the US later this year.
In addition, the company has submitted an application for a 25mg oral formulation of semaglutide for use in adults with obesity or overweight and cardiovascular disease, with a decision anticipated by year-end.
