FDA Approves Novo Nordisk's Rybelsus For Cardiovascular Risk Reduction In Type 2 Diabetes Patients

(RTTNews) - Novo Nordisk announced that the US Food and Drug Administration has approved Rybelsus—the only oral GLP-1 medication—for reducing the risk of major adverse cardiovascular events (MACE), including cardiovascular death, heart attack, and stroke, in adults with type 2 diabetes who are at high risk, regardless of prior cardiovascular history (covering both primary and secondary prevention). Results from the SOUL trial further reinforce the clinical profile of semaglutide, a molecule studied across multiple therapeutic areas.

This new indication makes Rybelsus the only oral GLP-1 medicine approved to reduce the risk of MACE in adults with type 2 diabetes who are at high risk for these events. It serves for both primary prevention (reducing the risk of major adverse cardiovascular events by preventing or managing risk factors in adults who are at high risk for these events) and secondary prevention (reducing the risk of another event in people who have had a serious CV event).

The FDA initially approved Rybelsus in 2019 as the first and only GLP-1 medicine in pill form, along with diet and exercise, to improve glycemic control for adults with type 2 diabetes.

Separately, Novo Nordisk has also submitted a supplemental application in the US for a once-daily oral formulation of semaglutide under the trade name Wegovy for the treatment of obesity. A decision is expected later this year.

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