Drugmaker Novo Nordisk said on Jan. 28 that the U.S. Food and Drug Administration (FDA) had approved Ozempic for lowering the risk of kidney failure and disease progression in adults with Type 2 diabetes.
The Danish drugmaker stated that the FDA’s approval was based on a study showing that once-weekly Ozempic injections helped lower the risk of kidney disease progression and heart-related death by 24 percent in patients with diabetes and chronic kidney disease, compared to a placebo.
The study was conducted in 2019 across 28 countries and involved 3,533 adults with Type 2 diabetes and chronic kidney disease. The patients were divided into two groups: one receiving Ozempic injections and the other treated with a placebo.
Ozempic belongs to the glucagon-like peptide-1 (GLP-1) class of drugs, which help lower blood sugar levels in Type 2 diabetes patients by increasing insulin release from the pancreas and slowing digestion.
“With this new indication, Ozempic stands out uniquely as the most broadly indicated GLP-1 RA [glucagon-like peptide-1 receptor agonist] in its class,” said Anna Windle, senior vice president for clinical development and medical and regulatory affairs at Novo Nordisk.
Chronic kidney disease is a common complication for patients with Type 2 diabetes, which can cause additional sickness, including increased risk of heart problems and death, Novo Nordisk said.
The company stated that chronic kidney disease affects around 37 million adults in the United States, with about 40 percent of patients with Type 2 diabetes also experiencing the condition.
“Chronic kidney disease is very serious and common in patients living with Type 2 diabetes and represents a critical need for adults living with these comorbidities,” Windle said. “This approval for Ozempic allows us to more broadly address conditions within cardiovascular-kidney-metabolic syndrome, which affects millions of adults and could have serious consequences if left untreated.”
The Epoch Times reached out to the FDA for comment but did not hear back by publication time.
Ozempic was first approved by the FDA in 2017 to help improve blood sugar levels in diabetic patients. In 2020, the FDA approved the drug for reducing the risk of major cardiovascular events, such as heart attack, stroke, or death, in diabetic patients with known heart disease.
NAION is considered the most common cause of sudden vision loss in people older than 50. Researchers examined data from 424,152 Danish patients diagnosed with Type 2 diabetes to investigate the link between Ozempic and increased NAION risk.
