Research & Development
Novo Nordisk submits two NDAs to US FDA for oral semaglutide and sNDA for Ozempic
21 March 2019 -

Global healthcare company Novo Nordisk A/S (CPH:NOVOB) announced on Wednesday the submission of two New Drug Applications (NDAs) to the US Food and Drug Administration (FDA) for oral semaglutide, a once-daily glucagon-like peptide-1 (GLP-1) analogue in a tablet, as well as a supplemental NDA (sNDA) for once-weekly Ozempic (semaglutide).

Reportedly, a NDA was submitted for oral semaglutide seeking approval for an indication for the treatment of adults with type 2 diabetes. A priority review voucher (PRV) has been applied to the NDA, leading to an anticipated review time of six months from the submission date, according to standard FDA review timelines.

According to the company, the submission for oral semaglutide for the treatment of glycaemic control in adults with type 2 diabetes is based on the results from 10 PIONEER clinical trials, which included 9,543 adults with type 2 diabetes. In the PIONEER programme, people treated with oral semaglutide achieved greater blood glucose reductions compared to sitagliptin, empagliflozin, liraglutide and placebo. In addition, oral semaglutide demonstrated greater reductions in mean body weight vs most comparators. Across the PIONEER trials, oral semaglutide had a safe and well-tolerated profile, with the most common adverse event being nausea.

The second NDA was submitted for oral semaglutide seeking approval for a cardiovascular (CV) risk reduction indication in adults with type 2 diabetes. The NDA for an oral semaglutide cardiovascular risk reduction indication has an anticipated 10-month review time from the submission date, according to standard FDA review timelines.

Finally, an sNDA was submitted for Ozempic for a cardiovascular risk reduction indication in adults with type 2 diabetes. The sNDA for an Ozempic cardiovascular risk reduction indication has an anticipated 10-month review time from the submission date, according to standard FDA review timelines.

These applications for the oral semaglutide and Ozempic cardiovascular risk reduction indications are based on the results of two cardiovascular outcomes trials (CVOTs) evaluating the effects of adding semaglutide or placebo to standard of care on the risk of cardiovascular events, PIONEER 6 with oral semaglutide and SUSTAIN 6 with Ozempic.

PIONEER is the global clinical trial programme for oral semaglutide that comprises 10 phase 3a clinical trials, including a cardiovascular outcomes trial, and involving 9,543 adults with type 2 diabetes across all 10 trials.

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