Danish pharmaceutical leader Novo Nordisk (NYSE: NVO) has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on its label extension bid for Ozempic (once-weekly subcutaneous semaglutide). The company is seeking to expand the indication of the GLP-1 receptor agonist to include the reduction of kidney disease progression risk in adults with type 2 diabetes and chronic kidney disease.
Positive Results from the Phase III FLOW Study
The CHMP’s endorsement is based on compelling results from the Phase III FLOW study, which demonstrated a statistically significant and superior 24% reduction in the risk of kidney disease progression, as well as cardiovascular and kidney-related death, compared to placebo. In addition to the primary endpoint, the risk of major cardiovascular events and all-cause mortality was reduced by 18% and 20%, respectively, in secondary endpoints.
Implications of the Label Extension for Ozempic
This positive opinion from the CHMP could lead to a significant expansion in the use of Ozempic, providing a new treatment option for patients with type 2 diabetes who are at risk of kidney disease progression. The potential label extension underscores Novo Nordisk’s commitment to addressing the complex needs of patients living with chronic conditions and highlights the importance of innovative therapies in improving patient outcomes.-Fineline Info & Tech
