FDA Approves Novo Nordisk's Oral Semaglutide, First GLP-1 in Pill Form on Sept. 20th. As a long-acting GLP-1 analog, semaglutide has a mechanism of action similar to GLP-1. And GLP-1 is a peptide hormone secreted by intestinal L cells, which, after specifically binding to the receptor, mainly gives play to the secretion of blood glucose-dependent incretin via the cyclic AMP signaling pathway. According to research, semaglutide could not only largely improve blood glucose of patients with type 2 diabetes but also decrease appetite and reduce food intake and induce weight loss. Besides, it could significantly reduce the risks of MACE of patients with type 2 diabetes. Semaglutide subcutaneous injection was approved by the FDA in Dec. 2017 to treat type 2 diabetes, with the trade name of Ozempic and 2018 sales reaching USD284 million.
Semaglutide subcutaneous injection has the same main ingredient as semaglutide tablets, with the only difference being that semaglutide tablets uses sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC) as the excipient and its safety and effectiveness have been proved in the PIONEER trials. Besides the difference in the administration method, those two dosage forms also have different administration frequencies, with the injection administered once weekly while tablets administered once daily. If semaglutide tablets is smoothly approved, it will have inestimable business prospects. The pharmaceutical market research institution EvaluatePharma predicts that semaglutide’s sales in 2024 will reach USD1.994 billion.
