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# FDA Reviewers Back Novo Nordisk’s New Diabetes Therapy
- URL: https://www.fdaweb.com/fda-reviewers-back-novo-nordisks-new-diabetes-therapy/
- Published: 2017-10-16T12:00:00.000Z
- Updated: 2026-09-14T22:56:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139871

FDA appears to be backing the approval of Novo Nordisk’s Glucagon-like peptide-1 (GLP-1) diabetes drug semaglutide as it heads for an advisory committee review 10/18\. In a [briefing document](https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM580460.pdf?ref=fdaweb.com) released in advance of the meeting, agency reviewers said the indication of semaglutide as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus is supported by efficacy data.

“Both doses of semaglutide (0.5 mg and 1.0 mg) demonstrated superiority to placebo, in terms of change in HbA1c from baseline, in a monotherapy trial as well as in atrial with basal insulin background therapy (Table 6),” FDA reviewers noted. “Both doses of semaglutide also demonstrated superiority to active comparators sitagliptin and insulin glargine for the HbA1c primary endpoint. Semaglutide 1.0 mg also demonstrated superiority to exenatide ER.”

On the safety side, the reviewers said safety data from Phase 3 studies (excluding a cardiovascular outcomes trial) “appear to be consistent with what has been seen with other GLP-1 receptor agonists.” However, they said the cardiovascular outcomes trial found that: “Subjects with a baseline history of retinopathy were more likely to experience retinopathy complications during the trial (8.2% of subjects on semaglutide, 5.2% on placebo) than subjects without a baseline history of retinopathy (0.7% on semaglutide, 0.4% on placebo). In our exploratory analysis, the group of subjects with baseline retinopathy and more than 1.5% HbA1c reduction from baseline to week 16 was found to have the highest observed risk of developing diabetic retinopathy complications.”

The reviewers recommended that post-approval data are “needed to assess whether a slower reduction in HbA1c among subjects with a history of retinopathy treated with semaglutide would result in a lower risk of retinopathy, or to assess the risk of retinopathy beyond two years of exposure.”