Ozempic Receives New Indication

January 16, 2020 – The U.S. FDA has approved a new indication for Ozempic® (semaglutide) injection 0.5mg or 1mg, manufactured by Novo Nordisk. Ozempic is now indicated to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults who have type 2 diabetes and known heart disease.

Patients who have type 2 diabetes are two to four times more likely to die from cardiovascular disease (CVD) than those who do not. High blood glucose, a complication of diabetes, can increase the risk of CVD, as can other risk factors that may occur alongside type 2 diabetes. These risk factors include high cholesterol and high blood pressure.

In a clinical trial, Ozempic reduced the risk of cardiovascular death, non-fatal heart attack, or non-fatal stroke by 26% compared to placebo. Recommended initial dosing is 0.25mg administered via subcutaneous injection once weekly for the first four weeks. The dose should then be increased to 0.5mg once weekly. If additional glycemic control is needed after four weeks at 0.5mg, the dose can be increased to 1mg per week. Ozempic can be taken at any time of day, with or without meals.

A black box warning cautions that semaglutide products are known to cause thyroid tumors in rodents. While it is unknown if these products cause such tumors in humans, Ozempic is contraindicated for use in patients who have a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2.

Ozempic first received FDA approval in 2017. It is also indicated as an adjunct to diet and exercise to improve glycemic control in adults who have type 2 diabetes mellitus.