The Food and Drug Administration has approved semaglutide (Rybelsus) tablets for the treatment of type 2 diabetes in adults who have not met their hemoglobin A1c goal. It is the first glucagonlike peptide–1 (GLP-1) analogue to be approved in pill form in the United States.
Olivier Le Moal/Getty Images
The approval was based on results from the PIONEER trials, a series of 10 studies that assessed semaglutide against sitagliptin, empagliflozin, and liraglutide in a total of 9,543 patients with type 2 diabetes. Patients who received semaglutide had reduced hemoglobin A1c levels as well as reduced body weight.
The most common adverse events reported during the PIONEER trials were nausea, abdominal pain, diarrhea, decreased appetite, vomiting, and constipation. The rate of adverse events were similar across trials.
“GLP-1 receptor agonists are effective medications for people with type 2 diabetes but have been underutilized, in part because until now, they have been available only as an injectable treatment. The availability of an oral GLP-1 receptor agonist represents a significant development, and primary care providers, specialists, and patients alike may now be more receptive to the use of a GLP-1 therapy to help them achieve their blood sugar goals,” said Vanita R. Aroda, MD, director of diabetes clinical research at Brigham and Women’s Hospital in Boston and PIONEER clinical trial researcher.
Semaglutide is approved for once-daily use, at doses of 7 mg and 14 mg. Find the full press release on the Novo Nordisk website.