NOVO NORDISK INC — Victoza FDA Review (NDA/BLA 022341, 2020)

Report summary

This FDA review details the approval of Novo Nordisk's Victoza (liraglutide) for reducing major adverse cardiovascular events (MACE) in adults with type 2 diabetes and established cardiovascular disease, based on the LEADER trial. The LEADER trial, involving 9340 patients, demonstrated Victoza significantly reduced MACE and all-cause death, leading to a supplemental NDA approval. Safety findings from various trials, including LEADER, were extensively reviewed. While Victoza consistently improved glycemic control and led to weight loss, concerns regarding thyroid C-cell tumors (with a boxed warning), pancreatitis, and gallstone disease were noted. The human relevance of rodent thyroid C-cell tumors remains unknown, and while some imbalances in pancreatic cancer cases were observed, no causal link was established. The trial also assessed immunogenicity, hypoglycemia, and renal safety, with overall similar rates to placebo for many adverse events, though acute gallstone disease was more frequent with liraglutide.

Key findings — cited to the page