FDA approves new indication for semaglutide in patients with T2D and CKD
Semaglutide 1.0 mg has been approved by the FDA to reduce the risk of kidney disease worsening, kidney failure and CV death in adults with T2D and CKD.
The FDA has approved a new indication for the injectable semaglutide 1.0 mg (Ozempic®) to reduce the risk of kidney disease worsening, kidney failure and CV death in adults with T2D and CKD. This decision by the FDA was based on the results of the phase 3b FLOW trial.
The FLOW trial was an international, randomized, double-blind, placebo-controlled, event-driven superiority trial, in which 3533 patients with T2D and CKD were randomized to 1.0 mg semaglutide once weekly or matching placebo, on top of standard care. The primary outcome was a composite of major kidney disease events, a composite of the onset of kidney failure (dialysis, transplantation, or an eGFR of <15 mL/min/1.73 m2), ≥50% reduction in the eGFR from baseline, kidney death or cardiovascular death. The FLOW trial was stopped early after meeting the efficacy criteria in the interim analysis. In FLOW, semaglutide reduced the risk of the primary composite outcome by 24% compared with placebo.
In December 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion to update the label of semaglutide 1.0 mg to reflect the data from the FLOW trial.