The Food and Drug Administration approved Eli Lilly’s Jardiance (empagliflozin) for treating adults with chronic kidney disease (CKD) on Friday morning.
The agency approved 10 mg tablets of Jardiance to reduce the risk of “sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death and hospitalization” in adults living with CKD.
Jardiance, which was developed by Lilly and Boehringer Ingelheim as part of the EMPOWER program, treats type 2 diabetes and heart failure. The drug was first approved as a SGLT-2 inhibitor in 2014 and has now received four FDA approvals in total.
Of note, Jardiance is not recommended for use to improve glycemic control in patients with type 1 diabetes as it may increase diabetic ketoacidosis. The same goes for patients with diabetes with an eGFR less than 30 mL/min/1.73 m.
The FDA made its decision based on data presented in the EMPA-KIDNEY trial, which found Jardiance demonstrated a 28% relative risk reduction, on top of standard care, compared with the placebo for the composite primary endpoint of kidney disease progression of cardiovascular death.
“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,” said Leonard Glass, MD, FACE, SVP of diabetes global medical affairs at Eli Lilly, in a statement. “Alongside the recent CKD approval for Jardiance in the EU, this decision further bolsters our efforts to support this community globally.”
Mohamed Eid, MD, MPH, MHA, VP of clinical development and medical affairs, cardio-renal-metabolism and respiratory medicine at Boehringer Ingelheim, added that due to the clinically demonstrated benefits of Jardiance, the company is “proud to now be able to offer this option to adults with CKD at risk for progression.”
The FDA approval for treating CKD comes weeks after the Biden administration announced the first 10 prescription drugs that have been selected for Medicare price negotiations under the Inflation Reduction Act.
Jardiance made the list and faces a loss of exclusivity in 2027. To that end, the brand spent nearly $74 million on TV ads in the first half of the year, a 5.7% boost versus the same period in 2022, according to iSpotTV.
Daniel Chancellor, director of thought leadership, consulting and analytics at Norstella’s Citeline, told MM+M earlier this month that Jardiance’s strategy makes sense as the drug has been seeking an expanded indication in CKD between now and 2026.
“Jardiance was already the highest current spend on DTC campaigns and I would expect that if that new indication is granted, we will see another uptick in order to drive market share,” he said.