Novo Nordisk announced the submission of two New Drug Applications (NDAs) to the US Food and Drug Administration (FDA) for 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.
Additionally, Novo Nordisk filed a supplemental NDA (sNDA) for once-weekly Ozempic® (semaglutide) injection 0.5 mg or 1 mg. The company is pursuing an indication to reduce the risk of MACE such as heart attack, stroke, or death in adults with type 2 diabetes and established CVD. The Ozempic® sNDA has an anticipated 10-month review time. Ozempic® was FDA approved on Dec 5, 2017 for adults with type 2 diabetes that along with diet and exercise may improve blood sugar.
"We are very excited about these three regulatory filings with the FDA as they represent a significant milestone for the company, but most importantly represent new potential treatment options for adults living with type 2 diabetes," said Todd Hobbs, vice president and US chief medical officer of Novo Nordisk. "We know that many adults with type 2 diabetes are still struggling to control their blood sugar and are at increased cardiovascular risk. We hope that, if approved, these products can help those patients."
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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 and Ozempic® cardiovascular risk reduction indications are 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 and SUSTAIN 6 with Ozempic®.