FDA Warns of Hypoglycemia Risk for Novo's Once-Weekly Insulin Before Adcomm

The U.S. Food and Drug Administration (FDA) has raised concerns about Novo Nordisk's proposed once-weekly insulin icodec due to an increased incidence of hypoglycemia in patients with type 1 diabetes (T1D). This issue will be a focal point during an upcoming advisory committee meeting scheduled for Friday.

In a briefing document, FDA reviewers noted a significantly higher rate of hypoglycemic episodes in T1D patients treated with insulin icodec compared to those using insulin degludec. While hypoglycemia is a common adverse reaction among insulin users, the reviewers pointed out that insulin icodec did not demonstrate additional glycemic control benefits over the existing insulin degludec in T1D patients.

Furthermore, the FDA reviewers expressed concerns about the lack of sufficient patient-focused data to determine whether T1D patients would prefer the once-weekly basal insulin option over the conventional once-daily injections.

Novo Nordisk is positioning insulin icodec as a long-acting insulin analog that offers a once-weekly dosing alternative to existing daily insulin products. According to Novo’s briefing document prepared for the advisory committee meeting, insulin icodec features a fatty acid side chain allowing it to bind to circulating albumin, creating a depot of inactive insulin. This depot facilitates the slow and continuous release of insulin icodec.

The ONWARDS clinical development program, conducted by Novo Nordisk, aimed to assess the impact of once-weekly insulin icodec on glycemic control. The program comprised six Phase III studies, but only one—ONWARDS 6—included patients with T1D. The results showed that insulin icodec was non-inferior to daily basal insulin in terms of glycemic control. However, the study also revealed a higher risk of clinically significant or severe hypoglycemic episodes in patients treated with insulin icodec.

Despite these findings, Novo Nordisk asserts that the hypoglycemia risks associated with insulin icodec can be effectively managed with proper guidance from healthcare professionals. The company argues that a once-weekly insulin option could offer a unique and valuable alternative treatment for some T1D patients.

In response to the FDA’s concerns, Novo Nordisk has proposed to include a warning about the hypoglycemia risk on insulin icodec’s label. The label will advise prescribers to limit the drug’s use to patients who have continuous glucose monitoring devices and exhibit low glycemic variability. Additionally, the label will recommend discontinuing insulin icodec if recurring hypoglycemia occurs.

The forthcoming advisory committee meeting will focus on evaluating the benefits and risks of insulin icodec for T1D patients. External experts will discuss whether the potential advantages of a weekly insulin dose outweigh the risks highlighted by the FDA.

As Novo Nordisk awaits the FDA’s decision, the company remains optimistic that insulin icodec could become an important treatment option for people living with T1D, provided that the hypoglycemia risks are carefully managed through physician guidance and patient monitoring.

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