First oral GLP-1RA approved in the USNews - Oct. 2, 2019
The US FDA has approved semaglutide tablets as an adjunct to diet and exercise to improve glycemic control in adults with T2DM. Oral semaglutide is the first approved glucagon-like peptide-1 (GLP-1) receptor agonist in a tablet, is an analogue of the naturally occurring hormone GLP-1. It is administered once daily and is approved for use in two therapeutic dosages, 7 mg and 14 mg.
Approval of oral semaglutide is based on the results from 10 PIONEER clinical trials which included 9,543 adults with type 2 diabetes. Oral semaglutide more effectively lowered blood sugar than sitagliptin and empagliflozin. Furthermore, treatment with oral semaglutide resulted in up to 4.4 kg reduction in body weight. Oral semaglutide demonstrated a safe and well-tolerated profile across the PIONEER programme, with the most common adverse event being mild to moderate nausea, which diminished over time.