Testimony to the FDA Gastrointestinal Drug Advisory Committee Regarding Solpura (Liprotamase) - Risk:Benefit Assessment and Ethics of Clinical Trials January 12, 2011 Michael Carome, M.D. Sidney Wolfe, M.D. Public Citizen Health Research Group (We ha

Public Citizen’s Health Research Group (We have no financial conflicts of interest) 1 FDA Assessment of the Benefits of Insulin Icodec in Adults With Type 1 Diabetes (Based on ONWARDS 6 Trial) • The efficacy of insulin icodec (a new once-weekly basal insulin) for glycemic control was noninferior to insulin degludec (a proven daily basal insulin) in terms of lower estimated mean changes in glycated. [...] • Periods of highest risk of icodec-induced hypoglycemia occurred on days 2 to 4, coinciding with the peak glucose-lowering effect of the drug. [...] 3 Attempt To Find a “Niche” Type 1 Diabetes Population for Icodec? • FDA considered “exploratory post hoc analyses” to identify type 1 diabetic patients with low glycemic variability as defined as percent coefficient of variation (%CV <36%), who had hypoglycemia risk comparable to the entire cohort of patients on insulin degludec, patients without a history of recurrent severe hypoglycemia or hypo. [...] • Public Citizen urges the advisory committee to vote “No” on the question regarding whether the applicant demonstrated that the benefits of insulin icodec outweigh its risks for improving glycemic control in adults with type 1 diabetes. [...] 11 Slide 1: Testimony to the FDA Endocrinologic and Metabolic Drugs Advisory Committee Regarding Insulin Icodec for Diabetes Patients May 24, 2024 Slide 2: FDA Assessment of the Benefits of Insulin Icodec in Adults With Type 1 Diabetes (Based on ONWARDS 6 Trial) Slide 3: FDA Assessment of Hypoglycemia Risk for Insulin Icodec in Adults With Type 1 Diabetes Slide 4: Attempt To Find a “Niche” Type 1.