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# Hypoglycemia Risk in Novo’s Weekly Insulin: FDA
- URL: https://www.fdaweb.com/hypoglycemia-risk-in-novos-weekly-insulin-fda/
- Published: 2024-05-22T12:00:00.000Z
- Updated: 2026-09-14T14:31:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157039

FDA medical reviewers say there was an increased risk of hypoglycemia in patients with Type 1 diabetes taking Novo Nordisk’s Awiqli (insulin icodec) once-weekly insulin. The reviewers’ comments are in a [briefing document](https://www.fda.gov/media/178821/download?ref=fdaweb.com) released in advance of a 5/24 meeting of the agency’s Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss Novo’s BLA.

The company hopes to be the first to offer a weekly insulin product as an alternative to daily insulin injections for patients with Type 1 and 2 diabetes.

While the company has proposed a label suggesting using continuous glucose monitoring devices for monitoring blood sugar in Type 1 diabetes patients, the reviewers say there is no clinical data to support Novo’s proposed methods for mitigating the risks associated with hypoglycemia.

The briefing document says data from the ONWARDS 6 trial showed higher incidence of level 2 (clinically significant) and level 3 (severe) hypoglycemia in those on insulin icodec compared to the active comparator, Novo Nordisk’s Tresida (insulin degludec) in patients with Type 1 diabetes.

FDA is asking the advisors to discuss:

- the benefits and risks of insulin icodec to improve glycemic control in adults with Type 1 diabetes and the balance of risks and benefits in the population;
- the role of continuous glucose monitoring devices and measures of glycemic variability to help reduce the risk of hypoglycemia in patients with Type 1 diabetes using insulin icodec;
- the proposed dosing and titration regimen and the extent to which the modeling data support alternative dosing strategies; and
- the role of insulin icodec in the context of the available treatment armamentarium for patients with Type 1 diabetes.