HQ Team
December 13, 2024: Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is backing the label update of Ozempic for showing reduced risks associated with chronic kidney disease (CKD) in adults with type 2 diabetes This update will reflect results from the FLOW kidney outcomes trial.
Findings from the FLOW trial
The FLOW trial demonstrated that semaglutide 1.0 mg resulted in a 24% reduction in the progression of kidney disease compared to placebo. Additionally, it showed cardiovascular benefits with an 18% reduction in major cardiovascular events. A 20% decrease in all-cause mortality was also seen in its uptake
Martin Holst Lange, executive vice president for development at Novo Nordisk, emphasized the importance of these results, stating, “Approximately 40% of people with type 2 diabetes develop chronic kidney disease, and there is a need for treatments that can help to reduce kidney disease progression.”
In a study done by the National Institutes of Health, a weekly injection of semaglutide was safe and reduced the amount of fat in the liver by 31% in people with HIV and metabolic dysfunction-associated steatotic liver disease.
With this positive backing, Ozempic becomes the first GLP-1 receptor agonist to demonstrate a reduction in kidney disease progression among adults with type 2 diabetes and CKD. Novo Nordisk has also submitted a label expansion application in the U.S., with a decision expected in the first half of 2025.
Concerns surrounding Ozempic
Despite its benefits, there have been concerns regarding Ozempic and similar GLP-1 receptor agonists as certain side effects have been observed.
There have been gastrointestinal side effects, including nausea, vomiting, and diarrhea, which can affect patient adherence to treatment.
Studies have indicated an increased risk of thyroid C-cell tumors in rodents, raising concerns about long-term safety. There have been reports linking GLP-1 receptor agonists to acute pancreatitis, necessitating caution among patients with a history of pancreatic issues.
Another concern is the high cost of Ozempic, which limits access for some patients, particularly those without adequate insurance coverage.
Novo Nordisk said in a statement that it stands by the safety and efficacy of its GLP-1drugs and added, “the known risks associated with use of these medicines are reflected in their current FDA- and EMA-approved product labeling.” The company said that it will continue to work with regulators to evaluate the risks.
In a statement, the FDA said that it “routinely evaluates individual adverse event reports and adverse event reports from the published literature for all approved drugs.”
“In general,” the agency said, “the FDA does not comment on third-party research or individual reports but may evaluate them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”
The positive opinion from the EMA marks a significant advancement for Ozempic as a treatment option for patients with type 2 diabetes and chronic kidney disease. While its benefits in reducing kidney disease progression are promising, ongoing monitoring of safety and long-term effects remains essential. As Novo Nordisk prepares for further regulatory decisions, healthcare providers must weigh the benefits against potential risks when considering Ozempic for their patients.
