Risk of Low Blood Sugar Identified in Novo Nordisk’s Once-Weekly Insulin Before FDA Review

Novo Nordisk aims to be the first to launch a weekly insulin product, particularly beneficial for diabetic patients with Type 1 and Type 2 who prefer fewer injections. However, there are concerns that this new treatment may lead to hypoglycemia, or low blood sugar levels more frequently.
On December 15, 2023, the FDA stated that additional data provided by Novo Nordisk represented a major amendment to the existing Biologics License Application (BLA) for insulin icodec and requested three more months for a detailed assessment. According to Novo Nordisk, the review is expected to be finalized in the third quarter of 2024.
In an FDA briefing document, the agency’s staff reported that patients with Type 1 diabetes experienced higher rates of hypoglycemic episodes while using insulin icodec compared to insulin degludec, another daily insulin marketed by Novo Nordisk under the Tresiba brand. Specifically, the data indicated that patients on insulin icodec experienced 50% to 80% more clinically significant or severe hypoglycemia compared to insulin degludec.

Another comparison measure was Time in Range (TIR) derived from continuous glucose monitoring (CGM), which is moderately associated with A1C levels. In the ONWARDS 6 trial, neither insulin icodec nor insulin degludec achieved the 70% TIR target set by the American Diabetes Association (ADA). Thus, there was no significant difference between the two treatments, and the point estimate was closer to the insulin degludec group.
For insulin icodec, Novo Nordisk is required to include a warning regarding the possibility of hypoglycemia, especially for people with Type 1 diabetes who are using CGM devices. It also proposed discontinuing the product in patients who frequently suffer from hypoglycemia. However, FDA staff argued that Novo Nordisk has not provided clinical evidence on how it plans to reduce these risks. Additionally, it was noted that no Phase 2 study was provided to identify the ideal dosing of insulin icodec and bolus insulin to regulate plasma glucose concentration variations in patients with Type 1 diabetes.

Despite these concerns, Novo Nordisk has tested insulin icodec in six Phase 3 trials involving over 4,000 adults with diabetes, although only one of these trials included patients with Type 1 diabetes. Efforts to innovate diabetes treatment continue, as insulin icodec received a positive vote from the European Medicines Agency’s Committee for Medicinal Products for Human Use based on Phase 3 data in April. If approved, the drug will be marketed in Europe under the brand name Awiqli.
While Novo Nordisk awaits the FDA’s decision, competition is also intensifying. Another contender in the category is Eli Lilly’s efsitora – a once-weekly insulin injection – which has achieved blood sugar reductions comparable to current daily insulins among patients with Type 2 diabetes.
The upcoming FDA advisory panel meeting will be crucial in determining if the use of insulin icodec is safe for the general public. Although the FDA is not bound by the recommendations of the advisory panel, it usually complies with them. The decision will not only impact Novo Nordisk but also influence the future landscape of diabetes treatment options.

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