FDA Approves Ozempic for Kidney Disease

Danish drug maker Novo Nordisk announced that the FDA has granted approval to its blockbuster drug Ozempic (semaglutide) to treat chronic kidney disease (CKD) in adults with type 2 diabetes. Ozempic can now be used to lower the risk of CKD progression, kidney failure, and cardiovascular-related death in that patient population.

The approval was based on late-stage FLOW trial results showing that the drug helped cut the risk of death from CKD and major cardiac events by 24%. Ozempic, a glucagon-like peptide-1 receptor agonist, is already approved to improve glycemic control for adults with type 2 diabetes and to reduce the risk of major cardiovascular events in adults with type 2 diabetes and known heart disease.

“Type 2 diabetes can be challenging enough to manage without the added risk of chronic kidney disease,” said Richard E. Pratley, MD, co-chair of the FLOW trial. “Today’s decision by the FDA offers hope for the millions of adults living with both conditions and provides an additional treatment option, representing a significant advancement for my patients.”

Source: Press release