FDLI Enforcement and Litigation Conference, Jill Furman, Director Office of Compliance, CDER, December 2025
A comparative efficacy trial (ARBITER6) also showed a significant reduction of baseline CIMT with extended-release nicotinic acid (2 g/day for 14 months), as opposed to ezetimibe (a cholesterol-lowering drug), in patients taking statins (84)
Blood Sugar Effects Both medications improve glucose metabolism: Liraglutide: HbA1c reduction of 0.5-1.0% at weight loss doses Originally developed for diabetes (Victoza) Modest glucose benefits at Saxenda doses Semaglutide: HbA1c reduction of 1.0-1.8% at diabetes doses Greater glucose improvement than liraglutide Significant benefit for prediabetes and diabetes For patients with diabetes or prediabetes, semaglutide provides greater metabolic benefit
The US Food and Drug Administration (FDA) requires any chronic weight management medication that works on the central nervous system to carry a warning about suicidal behavior and ideation
Another is continuous chromatography, which offers cost savings and a lower environmental footprint compared to batch HPLC
Your prescriber determines your target dose