The FDA approved semaglutide (Ozempic) to reduce the risk of kidney disease worsening, kidney failure, and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD), making it the only GLP-1 receptor agonist to be granted this indication, drugmaker Novo Nordisk announced.
The approval only applies to 0.5-mg, 1-mg, or 2-mg doses of semaglutide, which is already approved for adults with type 2 diabetes to improve glycemic control and to reduce the risk of major cardiovascular events in adults with known heart disease. It does not apply to 1.7 mg or 2.4 mg semaglutide (Wegovy), which is indicated for chronic weight management.
Chronic kidney disease is a common complication of type 2 diabetes; around 40% of people with type 2 diabetes also experience CKD.
The FDA’s decision was supported by the phase IIIb FLOW trial of 3,533 adults with type 2 diabetes and CKD. In FLOW, treatment with once-weekly 1-mg semaglutide yielded a 24% relative risk reduction (4.9% absolute risk reduction at 3 years) for the primary composite endpoint — a sustained decline in estimated glomerular filtration rate (eGFR) of ≥50%, sustained eGFR under 15 mL/min/1.73 m2, chronic renal replacement therapy, renal death, or cardiovascular death — compared with standard of care alone. The number needed to treat for 3 years to prevent one such event was 20.
The study was stopped early due to meeting pre-specified efficacy criteria after a median follow-up of 3.4 years.
“Type 2 diabetes can be challenging enough to manage without the added risk of chronic kidney disease, and I have seen in my own practice that patients with type 2 diabetes and chronic kidney disease need extra support from medications that may have a profound clinical impact by lowering the risk of major kidney and cardiovascular outcomes,” said FLOW trial co-chair Richard Pratley, MD, of the AdventHealth Diabetes Institute in Orlando, Florida, in a statement.
“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,” Pratley added.
The most common adverse reactions with semaglutide that occurred in 5% or more of patients include nausea, vomiting, diarrhea, abdominal pain, and constipation. The GLP-1 receptor agonist is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
The label also warns of the potential for acute pancreatitis, vision changes, hypoglycemia, acute kidney injury, severe gastrointestinal reactions, hypersensitivity, acute gallbladder disease, and pulmonary aspiration during anesthesia.
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