The US Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee is set to hold a meeting to assess the benefit-risk profile of Novo Nordisk's insulin icodec, to treat type 1 diabetes (T1D).
The discussion will revolve around a biologics licence application (BLA) submitted by Novo Nordisk, which seeks approval for once-weekly subcutaneous administration of insulin icodec, a long-acting human insulin analogue designed to provide glycaemic control in adults with diabetes.
In the single randomised, controlled Phase III ONWARDS 6 clinical trial, insulin icodec demonstrated a significantly higher rate of hypoglycaemic episodes compared to insulin degludec, raising concerns about its safety profile.
Though weekly insulin icodec was noninferior to daily insulin degludec in terms of efficacy, it was associated with a 48% to 89% increase in level 2/3 hypoglycaemia at week 26.
The peak glucose-lowering effect of insulin icodec, which happens between days two and four post-injection, corresponds with the highest risk period for hypoglycaemia.
In a briefing document, the FDA stated: “The patient-focused data collected in ONWARDS 6 were inadequate to inform whether patients with T1D preferred the once-weekly basal insulin option to once daily. In light of the available safety and efficacy data, FDA requests that the advisory committee focus its discussion on the benefits and risks of insulin icodec in patients with T1D.”
The study reported more hypoglycaemia-related serious adverse events in patients using insulin icodec versus insulin degludec.
Consequently, insulin icodec was observed to have a higher risk of clinically meaningful hypoglycaemia, without demonstrating a lower A1C advantage in the sole study conducted on T1D patients.
Novo noted in a briefing document that “while the risk of hypoglycaemia can be effectively managed by guidance provided from physicians considering the individual clinical situation, the availability of a weekly insulin could provide an important and unique alternative treatment option for some people living with T1D.”
