Novo Nordisk Wins EU Label Update For Rybelsus To Include Heart Benefits

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(RTTNews) - Novo Nordisk B A/S (NVO), Monday announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has approved a label update for Rybelsus to include cardiovascular benefits demonstrated in the SOUL trial.

The phase 3b study showed that oral semaglutide reduced the risk of major adverse cardiovascular events, including cardiovascular death, heart attack, and stroke, by 14 percent compared with placebo in adults with type 2 diabetes and cardiovascular or kidney disease.

New findings from SOUL, to be presented at the European Association for the Study of Diabetes meeting, also indicate that Rybelsus significantly lowered hospitalizations versus placebo.

With this approval, Rybelsus becomes the first and only oral GLP-1 receptor agonist available in the EU proven to improve both blood sugar control and cardiovascular outcomes. A U.S. decision on a similar label extension is expected later this year.

NVO is currently trading at $55.90, up $1.03 or 1.87 percent on the New York Stock Exchange.