January 16, 2020
The U.S. FDA has approved an update to the label for Rybelsus® (semaglutide) tablets, manufactured by Novo Nordisk. The label now includes data from the PIONEER 6 cardiovascular outcomes trial demonstrating cardiovascular safety.
During the trial, 3.8% of patients taking Rybelsus experienced at least one major adverse cardiovascular (CV) event compared to 4.8% of patients on placebo. Although Novo Nordisk applied for a label update indicating that Rybelsus reduces the risk of a major adverse CV event, the FDA has asked the company to complete the Phase 3 SOUL trial prior to the agency making a decision regarding the label.
Rybelsus received FDA approval in 2019 and is indicated as an adjunct to diet and exercise to improve glycemic control in adults who have type 2 diabetes mellitus. Like other semaglutide products, it carries a black box warning that semaglutide is known to cause thyroid tumors in rodents. As a result, Rybelsus is contraindicated for use in patients who have a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2.
Recommended dosing is 3mg once daily for the first 30 days, taken 30 minutes before the first food, beverage, or other oral medications of the day with no more than four ounces of plain water. Taking Rybelsus less than or more than 30 minutes before consuming food, drink, or other medication can affect its absorption in the body. After the first 30 days of treatment, dosage should be increased to 7mg once daily. If additional glycemic control is required after at least 30 days at 7mg, the dose can be increased to 14mg once daily. Patients transitioning from Ozempic® (semaglutide – Novo Nordisk) injection to Rybelsus can begin at a dose of 7mg or 14mg per day, as appropriate, rather than 3mg per day.