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# Novo Nordisk Plans Diabetes Drug NDA in 4th Quarter
- URL: https://www.fdaweb.com/novo-nordisk-plans-diabetes-drug-nda-in-4th-quarter/
- Published: 2016-05-02T12:00:00.000Z
- Updated: 2026-09-14T20:58:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135547

> Novo Nordisk says it will file in the fourth quarter an NDA for its diabetes drug semaglutide based on positive data from its sixth and last global Phase 3a trial, SUSTAIN6\. The new glucagon-like peptide-1 (GLP-1) analog, which is intended to be administered subcutaneously once weekly, achieved its primary endpoint of showing non-inferiority of major cardiovascular events when compared with placebo, and it showed a statistically significant reduction in cardiovascular risk, according to the company. “The safety profile of semaglutide in SUSTAIN6 was as expected and consistent with previous semaglutide clinical studies,” it adds.  
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> Semaglutide also induces weight loss by decreasing appetite and food intake, Novo Nordisk says. It is also being developed in an oral tablet version for treating Type 2 diabetes.