FDA approves new indication for Ozempic to lower kidney risks in type 2 diabetes, CKD
Key takeaways:
- FDA approved semaglutide to lower the risk for worsening kidney disease, kidney failure and CV death in type 2 diabetes and CKD.
- Semaglutide lowered the risk for kidney disease events by 24% in the FLOW trial.
The FDA has approved a new indication for semaglutide to lower the risk for worsening kidney disease, kidney failure and cardiovascular death among adults with type 2 diabetes and chronic kidney disease, Novo Nordisk announced.
Semaglutide 1 mg (Ozempic, Novo Nordisk) is a once-weekly subcutaneous GLP-1 originally approved to improve glycemic control for adults with type 2 diabetes in December 2017. The FDA approved a new indication for semaglutide to treat adults with type 2 diabetes plus CKD based on results from the FLOW trial. As Healio previously reported, adults with type 2 diabetes and CKD receiving semaglutide had a 24% lower risk for kidney disease events, a 20% reduced risk for all-cause mortality and an 18% lower risk for CVD compared with those receiving placebo in the FLOW trial. Prior to the approval of the drug’s new indication, Matthew Weir, MD, professor and chief of the division of nephrology at University of Maryland School of Medicine, said he felt the FLOW trial findings made semaglutide “choice No. 1” for glucose control and reducing risk for cardiometabolic disorders.
“Type 2 diabetes can be challenging enough to manage without the added risk of CKD, and I have seen in my own practice that patients with type 2 diabetes and CKD need extra support from medications that may have a profound clinical impact by lowering the risk of major kidney and CV outcomes," Richard E. Pratley, MD, medical director at the AdventHealth Diabetes Institute in Orlando, co-chair of the FLOW Trial and a Healio | Endocrine Today co-editor, said in a press release. "A large portion of patients I treat experience serious kidney complications and comorbidities, with some even requiring dialysis. 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."
The FDA’s approval of a new indication is a “welcomed addition” to the therapies available to treat CKD, according to Kevin M. Pantalone, DO, ECNU, FACE, professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, director of diabetes initiatives and staff endocrinologist in the department of endocrinology at Cleveland Clinic.
“This new CKD indication for Ozempic is very important, as individuals with CKD are five times more likely to die from CV causes than to develop end-stage kidney disease,” Pantalone told Healio. “This new indication will not only allow us to reduce the risk of progression of CKD, or development of end-stage kidney disease in adults with CKD and type 2 diabetes, but will also aid in addressing the elevated CV risk that exists in that population.”
The new indication is the most recent one approved for Ozempic. As Healio previously reported, the FDA approved a new indication for Ozempic in January 2020 to lower the risk for major adverse CV events in adults with type 2 diabetes and known CVD.
"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," Anna Windle, PhD, senior vice president of clinical development, medical and regulatory affairs at Novo Nordisk, said in a press release. "With this new indication, Ozempic stands out uniquely as the most broadly indicated GLP-1 receptor agonist in its class. We are proud to continue advancing innovations that will have a meaningful impact for this patient population, underscoring Novo Nordisk's commitment to cardiometabolic care."
For more information:
Kevin M. Pantalone, DO, ECNU, FACE, can be reached at PANTALK@ccf.org.
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