First oral GLP-1RA approved in the US
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.
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