The new indication for semaglutide adds to the long list of conditions that the GLP-1 receptor agonist has been approved for, and provides a new option for high-risk patients with these chronic conditions.
The FDA approved semaglutide (Ozempic; Novo Nordisk) to reduce the risk of worsening kidney disease, kidney failure, and death due to cardiovascular disease in adult patients with type 2 diabetes (T2D) and chronic kidney disease (CKD), according to a news release from Novo Nordisk.1
"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,” Anna Windle, PhD, senior vice president of clinical development at Novo Nordisk, said in the news release. “This approval for [semaglutide] 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.”1
The approval adds to semaglutide’s approved indications, including improving glycemic control for adults with T2D and reducing the risk of major cardiovascular events in adults with known heart disease.2,3,4
Results from the randomized, double-blind, placebo-controlled phase 3b FLOW trial (NCT03819153) provided the basis for the FDA’s regulatory decision, which were presented by investigators at the 84th Annual Scientific Sessions of the American Diabetes Association. The trial was stopped early upon the recommendation of an independent monitoring committee due to the pre-specified efficacy end point being met after a median 3.4 years of follow-up.1,5
Trial Name: A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease (FLOW)
ClinicalTrials.gov ID: NCT03819153
Sponsor: Novo Nordisk A/S
Completion Date: January 9, 2024
In the trial, which enrolled a total of 3533 patients with T2D or CKD, once weekly semaglutide 1 mg led to a 24% reduction in the risk of kidney disease progression and kidney and cardiovascular mortality compared with placebo (331 vs 410 events; HR: 0.76 [0.66, 0.88]; P = .0003).5
Data also indicated that semaglutide 1 mg demonstrated superiority to placebo for all secondary outcomes, including inducing a significant reduction in mean annual glomerular filtration rate slope and a significant reduction in the risk of major cardiovascular events in patients treated with the GLP-1 receptor agonist (RA). Patients treated with semaglutide experienced 212 cardiovascular events, compared with 254 events for the placebo group; furthermore, there was a meaningfully lower risk of death in the semaglutide group compared with the placebo group.5
"A large portion of patients I treat experience serious kidney complications and comorbidities, with some even requiring dialysis,” Richard E Pratley, MD, co-chair of the FLOW trial, said in the news release. “Today's decision by the FDA offers hope for the millions of adults living with both conditions and provides an additional treatment option, representing a significant advancement for my patients."1
Pharmacists have an outsized role in guiding patients with T2D or CKD regarding treatment with GLP-1 RAs. These medications have the potential to provide life-changing impacts for patients struggling with worsening kidney disease or those concerned about their increased cardiovascular disease risk. For patients to safely use these medications, pharmacists are essential, as they can educate patients on whether a GLP-1 RA is the right treatment for them while ensuring the correct dosing and administration of the medication.
