FDA fast tracks empagliflozin for treatment of chronic kidney disease
The FDA on Thursday granted fast track designation for the investigation of the SGLT2 inhibitor empagliflozin to reduce the risks for renal disease progression and cardiovascular death in adults with chronic kidney disease, according to a press release from Boehringer Ingelheim and Eli Lilly.
The fast track designation is based on the ongoing EMPA-Kidney clinical study, which is evaluating the effect of empagliflozin (Jardiance) on the progression of kidney disease and the occurrence of CV death among adults with established CKD with and without diabetes.
"Chronic kidney disease can have a devastating impact on people's lives. Not only does it cause damage to the kidneys that can eventually lead to the need for dialysis or transplant, but it could also increase the risk of cardiovascular death," Mohamed Eid, MD, MPH, MHA, vice president of clinical development and medical affairs for Boehringer Ingelheim, said in the release. "Chronic kidney disease is a common and deadly condition, and there are still only limited treatment options, which is what motivates us to explore the potential role Jardiance may play in improving outcomes."
Empagliflozin, approved by the FDA in 2014, is a once-daily tablet indicated to lower blood glucose in adults with type 2 diabetes and to reduce the risk for CV death in adults with type 2 diabetes and known CVD.
"We recognize the close link between the health of the heart, kidneys and metabolic system, and we have committed to a broad clinical development program assessing the cardiorenal metabolic benefits of Jardiance," Jeff Emmick, MD, PhD, vice president of product development for Lilly, said in the release. "The Fast Track designation from the FDA is an important step in evaluating the potential of Jardiance to enhance care for those with chronic kidney disease."
For EMPA-Kidney, researchers will recruit about 6,000 participants to receive either 10 mg empagliflozin once daily or placebo in addition to standard of care, according to the release. The primary outcome is defined as time to a first event of either CV death or kidney disease progression, defined as end-stage renal disease (ESRD), a sustained decline in estimated glomerular filtration rate to less than 10 mL/min/1.73 m2, renal death or a sustained decline of at least 40% in eGFR from randomization.
As Healio previously reported, the FDA granted fast track designation for empagliflozin in June for the reduction of risk for CV death and hospitalization for heart failure among adults with chronic heart failure. That designation is for the ongoing EMPEROR program, which consists of the EMPEROR-Reduced and EMPEROR-Preserved studies. These studies will evaluate the effect of empagliflozin on CV death and hospitalization for heart failure among adults with chronic heart failure with reduced or preserved ejection fraction, respectively.
In a meta-analysis of four recent CV and kidney outcomes trials assessing the use of SGLT2 inhibitors among patients with type 2 diabetes, published in The Lancet Diabetes & Endocrinology in September and reported by Healio, researchers found that the drug class offers nephroprotective benefits across all levels of kidney function, regardless of albuminuria status. Researchers found that SGLT2 inhibitors substantially reduced the composite risk for dialysis, transplantation or renal death by 33% (RR = 0.67; 95% CI, 0.52-0.86), with the observed effect consistent across the four trials (P for heterogeneity = .53). SGLT2 inhibitors also reduced ESRD by 35% (RR = 0.65; 95% CI, 0.53-0.81) and risk for acute kidney injury by 25% (RR = 0.75; 95% CI, 0.66-0.85).
Fast track is a designation of an investigational drug for expedited review to facilitate the development of drugs that treat a serious or life-threatening condition and fill an unmet medical need, according to the FDA. The designation must be requested by the drug company. – by Regina Schaffer
Disclosures: Eid is vice president of clinical development and medical affairs for Boehringer Ingelheim. Emmick is vice president of product development for Lilly.