Shares of Novo Nordisk A/S (NYSE:NVO) gained 2.8% in premarket trading on Monday after the European Medicines Agency (EMA) authorized an update to the Rybelsus label, highlighting cardiovascular benefits for adults with type 2 diabetes.
The revised labeling for oral semaglutide (Rybelsus) is based on findings from the SOUL clinical trial, which demonstrated that the drug lowered the risk of cardiovascular death, heart attack, and stroke by 14% compared with placebo when added to standard care in high-risk type 2 diabetes patients.
With this new approval, Rybelsus becomes the first oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) in the EU to show proven cardiovascular benefits for people with type 2 diabetes. The medication mimics a natural hormone that helps control blood sugar, appetite, and digestion.
“Heart problems are the leading cause of disability and death for people living with type 2 diabetes,” said Emil Kongshøj Larsen, executive vice president of International Operations at Novo Nordisk.
Further results from the SOUL trial will be shared at the European Association for the Study of Diabetes Annual Meeting later this month, including data showing that oral semaglutide significantly reduced hospitalizations due to serious adverse events compared with placebo.
Novo Nordisk also anticipates a decision later this year regarding a cardiovascular indication label extension for Rybelsus in the United States. The company has submitted a separate U.S. application for a once-daily 25 mg oral semaglutide formulation for adults with obesity or overweight and cardiovascular disease.
Rybelsus was first introduced in 2019 as the pioneering oral GLP-1 receptor agonist approved for the treatment of type 2 diabetes.
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