Semaglutide Receives FDA Approval for New Indication, Reducing Risk of Kidney Disease Progression and Death by 24%

Feb 05, 2025 09:49 CST Updated 09:49

Novo Nordisk

Insulin Developer and Manufacturer

｜Edited by the Content Team of Zhong Peptide Biochemical

January 202528DayNovo Nordisk announced that Ozempic (1.0mg semaglutide) has been approved to reduce the risk of cardiovascular disease progression, kidney failure (end-stage renal disease), and death in adults with type 2 diabetes and chronic kidney disease (CKD). Semaglutide is the first GLP-1 treatment option for these patients.

The FDA's approval this time is mainly based on the primary results of the Phase IIIb FLOW study. This study was a randomized, double-blind, placebo-controlled superiority trial (n=3533), evaluating the efficacy and safety of Ozempic (1.0mg semaglutide) versus placebo as an adjunctive treatment to standard-of-care renal outcomes in preventing the progression of kidney damage and reducing the risk of renal and cardiovascular death in patients with type 2 diabetes and CKD. CKD was defined as 50≤ estimated glomerular filtration rate (eGFR) ≤75mL/min/1.73m² and 300< urine albumin-to-creatinine ratio (UACR) <5000mg/g, or 25≤eGFR<50mL/min/1.73m² and 100<UACR≤300mg/g.

The FLOW study was terminated early on October 10, 2023, due to outstanding efficacy. The results showed that, compared with the placebo group, the risk of kidney disease progression and cardiovascular and renal death in the Ozempic group was reduced by 24%, reaching the superiority endpoint. In addition, the study also met the superiority criteria for confirmatory secondary endpoints. In terms of safety, Ozempic demonstrated good safety and tolerability, consistent with previous studies.

According to statistics, there are approximately 37 million adults with CKD in the United States. CKD is a common complication of type 2 diabetes, with about 40% of type 2 diabetes patients developing CKD. CKD imposes a heavy economic and physical burden on patients with type 2 diabetes and may lead to other complications, increasing the risk of cardiovascular events and mortality.

About Semaglutide

Semaglutide is a GLP-1 receptor agonist that stimulates insulin production, inhibits glucagon secretion, and reduces appetite and food intake. Semaglutide was initially developed as a treatment for type 2 diabetes.ApprovedLaunched (brand name: Ozempic), in view of its significant effect on weight loss, the FDA in June 2021ApprovalIt is used to treat ordinary obese patients (brand name: Wegovy), which is the first new drug approved by the U.S. FDA for controlling common obesity or overweight since 2014. The drug was further approved by the EU for the treatment of obesity indications later in the same year.

AboutNovo Nordisk

Novo Nordisk, founded in 1923, is a global leading biopharmaceutical company headquartered in Copenhagen, the capital of Denmark. Our goal is to drive change to defeat diabetes and other serious chronic diseases such as obesity, rare blood disorders, and endocrine disorders. To achieve this, we lead scientific breakthroughs, expand the accessibility of our medicines, and are committed to preventing and ultimately curing these diseases. Novo Nordisk has approximately 47,000 employees across 80 countries and regions worldwide, delivering products and services to more than 168 countries and regions globally.

Source:

1.Pharmcube