FDA panel reviews Novo Nordisk insulin icodec for T1D

Novo Nordisk is pursuing approval from the US FDA for a new diabetes treatment option: a once-weekly subcutaneous injection of insulin icodec. This application will be scrutinized by the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, which will evaluate the potential benefits and risks associated with its use in treating type 1 diabetes (T1D).

Insulin icodec is a long-acting human insulin analogue developed to offer glycaemic control for adults with diabetes. The focus of the advisory committee's assessment will be on a biologics licence application (BLA) submitted by Novo Nordisk. The clinical evaluation of insulin icodec has raised some safety concerns, especially regarding its association with higher rates of hypoglycaemic episodes compared to existing treatments.

The primary data supporting the BLA comes from the ONWARDS 6 clinical trial, a single randomised, controlled Phase III study. This trial revealed that insulin icodec led to significantly more hypoglycaemic events than insulin degludec. Specifically, the incidence of level 2/3 hypoglycaemia, which is moderate to severe, increased by 48% to 89% at the 26-week mark.

The timing of insulin icodec’s peak glucose-lowering effect, occurring between days two and four after injection, coincides with the period of highest risk for hypoglycaemia. This raises additional concerns about the safety of the treatment. The FDA has noted that the data collected did not adequately address whether patients with T1D would prefer a once-weekly basal insulin over a daily regimen. Therefore, the advisory committee’s discussion will center on balancing the benefits and risks of this new treatment option.

The ONWARDS 6 study also highlighted a higher incidence of serious adverse events related to hypoglycaemia in patients using insulin icodec compared to those using insulin degludec. Moreover, insulin icodec did not demonstrate a significant advantage in lowering A1C levels, an important indicator of long-term blood glucose control, in T1D patients.

Despite these findings, Novo Nordisk argues that the hypoglycaemia risk can be managed with proper physician guidance tailored to each patient's clinical situation. The company believes that offering a weekly insulin option could be a valuable alternative for some individuals living with T1D, potentially improving their quality of life by reducing the frequency of injections.

The FDA’s forthcoming meeting will be crucial in determining whether insulin icodec can be a viable treatment option for those with type 1 diabetes. The key question will be whether the convenience of a weekly injection outweighs the increased risk of hypoglycaemia and other safety concerns.

In summary, Novo Nordisk’s insulin icodec is under consideration for approval as a once-weekly treatment for type 1 diabetes. While it offers the convenience of fewer injections, the higher risk of hypoglycaemia compared to daily insulin degludec is a significant concern that the FDA’s advisory committee will need to address. The outcome of this evaluation will determine if insulin icodec can provide a new, effective treatment option for individuals managing type 1 diabetes.