FDA approves Novo Nordisk's Ozempic to treat chronic kidney disease in those with diabetes, expanding its use
The Food and Drug Administration on Tuesday approved Novo Nordisk's Ozempic to treat chronic kidney disease in patients who also have Type 2 diabetes, expanding the use of the wildly popular injection in the U.S.
The drug is already widely used and covered to treat Type 2 diabetes. The FDA's decision means Ozempic can now be used to reduce the risk of kidney disease worsening, kidney failure, and death from cardiovascular disease in patients with both chronic kidney disease and diabetes.
The decision could transform how doctors treat patients with chronic kidney disease, which involves a gradual loss of kidney function and is one of the leading causes of death in the U.S. Around 37 million American adults are living with chronic kidney disease, according to Novo Nordisk.
Diabetes is a key risk factor for kidney disease. Roughly 40% of Type 2 diabetes patients have the condition, which can cause additional sickness such as increased risk of cardiovascular problems and death, Novo Nordisk said.
"All chronic kidney disease is progressive. It's a year-on-year, relentless decline in renal function," Stephen Gough, Novo Nordisk's global chief medical officer, said in an interview, referring to the kidney's ability to filter waste from the blood.
He noted that when the condition progresses to the point of kidney failure — also known as end-stage kidney disease — patients require long-term dialysis treatments to remove waste from the blood, or a kidney transplant. Both are burdensome, and death among patients with end-stage kidney disease is "very high," particularly from cardiovascular disease, according to Gough.
The approval also demonstrates that a blockbuster class of diabetes and weight loss drugs called GLP-1s have significant