Testimony Before the Food and Drug Administration’s (FDA’s) Endocrinologic and Metabolic Drugs Advisory Committee Regarding the Safety and Efficacy of Insulin Icodec in Diabetic Patients

To contextualize our position, I would like to start by the FDA’s summary of the benefits versus hypoglycemia risks of insulin icodec (hereafter, icodec), a new ultra-long-acting insulin analog biological drug proposed by Novo Nordisk to improve glycemic control in adults with diabetes mellitus. [...] Efficacy • The efficacy of icodec for glycemic control was noninferior to insulin degludec (hereafter, degludec), a proven daily basal insulin, in terms of lower estimated mean changes in glycated hemoglobin (HbA1c) at week 26 of follow-up.2 However, at week 52 of follow-up, the reduction numerically favored degludec. [...] Public Citizen May 24, 2024, Testimony Regarding Insulin Icodec • The higher icodec-induced hypoglycemia rate also was associated with a higher rate of hypoglycemia-related adverse events.5 • Periods of highest risk of icodec-induced hypoglycemia occurred on days 2 to 4, coinciding with the peak glucose-lowering effect of the drug. [...] • The FDA should consider the benefit-risk profile of icodec for both type 1 and type 2 diabetes because icodec is not “peakless” at its proposed once-weekly dose.7 o Numerous factors (such as fasting, exercise, illness, infections, menstruation, and surgery) pose challenges for icodec dosing and affect the frequency and intensity of hypoglycemia. [...] • Public Citizen urges the advisory committee to vote “No” on the voting question regarding whether the applicant demonstrated that the benefits of icodec outweigh its risks for improving glycemic control in adults with type 1 diabetes.