The FDA has granted priority review for a supplemental New Drug Application (sNDA) for canagliflozin to decrease the risk of adverse renal and cardiovascular outcomes in adult patients with type 2 diabetes and chronic kidney disease (CKD).
If approved for this indication, canagliflozin, which is marketed as Invokana, would be the first and only therapy in almost 20 years indicated to treat CKD in patients with type 2 diabetes when added to current standard of care, according to a press release issued by the drug’s maker, Janssen Pharmaceutical Companies of Johnson & Johnson.
Janssen filed the sNDA in March based on findings from the CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) trial. The trial was discontinued early following a planned interim analysis on the recommendation of the study’s data and safety monitoring committee. At the time the trial was stopped, 4401 patients with type 2 diabetes and CKD had been randomly assigned to receive canagliflozin, which is an inhibitor of sodium-glucose cotransporter 2, or placebo.
After a median follow-up duration of 2.62 years, canagliflozin-treated patients had a statistically significant 30% lower risk of the trial’s primary composite outcome of end-stage renal disease (ESRD), doubling of serum creatinine level, or death from renal or cardiovascular causes compared with placebo recipients, Vlado Perkovic, MBBS, PhD, of the George Institute for Global Health, University of New South Wales, Sydney, Australia, and colleagues reported at the 2019 World Congress of Nephrology in Melbourne, Australia. Results were published simultaneously in The New England Journal of Medicine.
In addition, the treatment group had a statistically significant 32% decreased risk of ESRD (need for dialysis or a kidney transplant or a sustained estimated glomerular filtration rate (eGFR) below 15 mL/min/1.73 m2), 20% decreased risk of cardiovascular death, myocardial infarction (MI), or stroke, and 39% decreased risk of hospitalization for heart failure.
Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019; published online ahead of print.