Novo Nordisk gains US FDA green light for its oral semaglutide

22 September 2019

Novo Nordisk (NOV: N) late Friday day announced the much awaited US Food and Drug Administration approval of its first-of-a-kind oral diabetes drug Rybelsus (semaglutide), as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, with the news sending the Danish diabetes giant’s shares up 2.59% to 350.50 Danish kroner in late trading.

Rybelsus, the brand name for oral semaglutide in the USA, is the first approved glucagon-like peptide-1 (GLP-1) receptor agonist in a tablet. The approval of Rybelsus is based on the results from 10 PIONEER clinical trials which included 9,543 adults with type 2 diabetes. Rybelsus more effectively lowered blood sugar than sitagliptin and empagliflozin. Furthermore, treatment with Rybelsus resulted in up to 4.4kg reduction in body weight.

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