FDA

Ozempic now approved for kidney disease in patients with T2DM

January 29, 2025

FDA approved Ozempic (semaglutide) to reduce risk of kidney disease progression, end-stage kidney disease, and death due to CV disease in adults with type 2 diabetes (T2DM) and chronic kidney disease (CKD).

Efficacy

Approval for the new indication was based on data from the phase 3b FLOW trial (NCT03819153) that evaluated the effect of once-weekly SC Ozempic on major kidney and CV outcomes in adults with T2DM and CKD. The trial achieved its primary endpoint with Ozempic 1 mg showing a statistically significant and superior 24% relative risk reduction of kidney disease progression, end-stage kidney disease, and death due to CV disease (4.9% absolute risk reduction at 3 years) compared with placebo, when added to standard of care.

Safety

The most common adverse reactions (≥5% of patients treated with Ozempic) were nausea, vomiting, diarrhea, abdominal pain, and constipation.

Source:

FDA approves Ozempic® (semaglutide) as the only GLP-1 RA to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. Novo Nordisk. 2025. https://www.multivu.com/novo-nordisk/9314951-en-ozempic-ckd-fda-approval

Ozempic. Package insert. Novo Nordisk. Accessed January 28, 2025. https://www.novo-pi.com/ozempic.pdf