FDA approves Jardiance to treat adults with CKD
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Key takeaways:
- Jardiance had a 28% relative risk reduction for kidney disease progression vs. placebo.
- The drug also showed a significant reduction in hospitalization risk in patients with CKD.
The FDA approved Jardiance 10 mg tablets to lower the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease at risk of progression, a press release noted.
“Following previous indications for Jardiance in heart failure and type 2 diabetes, this FDA approval now provides physicians, including nephrologists, with an important treatment option for adults living with CKD at risk for progression,” Leonard Glass, MD, FACE, senior vice president of diabetes global medical affairs at Lilly, said in the release from Boehringer Ingelheim Pharmaceuticals, and Eli Lilly and Company.
The endorsement of Jardiance (empagliflozin, Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company) comes after results of the EMPA-KIDNEY phase 3 trial — a multinational, randomized, double-blind, placebo-controlled clinical study — designed to assess the effects of the drug in adults at risk of CKD progression.
Among a wide range of patients, “empagliflozin therapy led to a lower risk of progression of kidney disease or death from cardiovascular causes than placebo,” lead study researcher William G. Herrington, MA, MBBS, MD, FRCP, of the Nuffield Department of Population Health at the University of Oxford, England, and colleagues wrote in the study.
The trial included 6,609 adults (with or without diabetes) from eight countries with CKD. Patients had an eGFR of at least 20 mL/min/1.73 m2 but less than 45 mL/min/1.73 m2, or 45 mL/min/1.73 m2 but less than 90 mL/min/1.73 m2; as well as a urine albumin-to-creatinine ratio of at least 200 mg/g.
Participants were deemed suitable for treatment with an SGLT2 inhibitor by a local investigator and were randomly selected for once-daily Jardiance or a placebo.
The primary outcome was time to a first event of cardiovascular death or kidney disease progression, defined as ESKD requiring dialysis or transplantation; sustained eGFR decline to less than 10 mL/min/1.73 m2; kidney death; or a consistent eGFR decline of at least 40%.
Results indicated that during a median of 2 years, Jardiance had a 28% relative risk reduction for the composite primary endpoint of kidney disease progression or cardiovascular death vs. placebo when administered with standard care.
In addition, EMPA-KIDNEY is the first SGLT2 inhibitor CKD trial to demonstrate a significant reduction in the risk of first and recurrent hospitalization in adults with CKD, according to the researchers. Jardiance showed a 14% relative risk reduction for hospitalization vs. placebo. Specifically, in the Jardiance group, 1,611 hospitalizations occurred among 960 patients, whereas for placebo, 1,895 hospitalizations occurred among 1,035 patients. Rates of adverse events were similar between the Jardiance and placebo groups, and results were consistent among patients with or without diabetes.
“Hospitalizations account for a third to a half of total health care costs for this population, and disease progression often leads to serious cardiovascular complications and kidney failure, which can require dialysis or transplantation,” Mohamed Eid, MD, MPH, MHA, vice president of clinical development and medical affairs at Boehringer Ingelheim, said in the release. “Given the clinically demonstrated benefits of Jardiance, we are proud to now be able to offer this option to adults with CKD at risk for progression.”
This FDA approval marks the fourth for Jardiance as part of its EMPOWER program, which has enrolled more than 700,000 adults worldwide in clinical trials and aims to improve outcomes for people living with cardio-renal-metabolic conditions.
Reference:
Herrington WG, et al. N Engl J Med. 2023;doi.org/10.1056/NEJMoa2204233.
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