OG 217SC filed with the FDA for type 2 diabetes

Novo Nordisk announced the submission of two New Drug Applications (NDAs) to the FDA for OG 217SC (oral semaglutide), the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist in a pill. One NDA was submitted seeking approval as an adjunct to diet and exercise to improve blood sugar in adults with type 2 diabetes. Novo Nordisk has submitted a priority review voucher (PRV) for this NDA with an anticipated review time of six months. The second NDA for oral semaglutide seeks approval for an indication to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults with type 2 diabetes and established cardiovascular disease (CVD) and has an anticipated 10-month review time.

The efficacy and safety of oral semaglutide was evaluated in 10 PIONEER clinical trials, which included 9,543 adults with type 2 diabetes. In the PIONEER program, people treated with oral semaglutide were compared to those taking sitagliptin, empagliflozin, liraglutide, and placebo. The applications for the oral semaglutide cardiovascular risk reduction indication is based on the results of two cardiovascular outcomes trials (CVOTs) examining the effects of adding semaglutide or placebo to standard of care on the risk of MACE in adults with type 2 diabetes and established CVD; PIONEER 6 with oral semaglutide.

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