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FDA grants Semaglutide breakthrough therapy qualification for NASH

October 30th., 2020, Novo Nordisk announced its performance in the first three quarters of fiscal year 2020, and said, the US FDA has granted Semaglutide a breakthrough treatment qualification for the treatment of NASH. Based on the previously disclosed phase II clinical data, Novo Nordisk expects to start a phase III clinical trial of Semaglutide in the treatment of NASH in 2021.

Semaglutide is a long-acting glucagon like peptide-1 (GLP-1) analogue. Its original research company is Novo Nordisk, a Danish pharmaceutical giant. Currently, Semaglutide is used for type II diabetes. Glucagon like peptide-1 (GLP-1) is a kind of "incretin" naturally secreted by human gastrointestinal mucosa. After binding with its receptor, GLP-1 activates intracellular cAMP and mitogen activated protein kinase (MAPK) pathways, reduces glucagon concentration, inhibits glucagon secretion, enhances cell sensitivity to insulin and promotes insulin secretion.

Semaglutide can delay gastric emptying and inhibit appetite and reduce blood glucose, which can significantly improve blood glucose level in patients with type II diabetes mellitus, and has a low risk of hypoglycemia; at the same time, it can induce weight loss by reducing appetite and food intake. In addition, it can significantly reduce the risk of major cardiovascular events in patients with type II diabetes, and has significant hypoglycemic and weight loss effects.

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