After a series of wins in heart failure, Eli Lilly and Boehringer Ingelheim are pumping the breaks on a late-stage Jardiance trial in chronic kidney disease (CKD) thanks to “clear positive efficacy."
Following an interim assessment, the independent data monitoring committee in charge of Lilly and BI’s phase 3 Empa-Kidney study have recommended the trial stop early. At the trial’s midpoint, Jardiance met the mark for positive efficacy, the partners said in a release.
Back in March 2020, Jardiance, also known as empagliflozin, scored an FDA fast track designation in its bid for an approval to reduce the risk of kidney disease progression and cardiovascular death in adults with CKD. Lilly and BI say they will unveil full Empa-Kidney results at an upcoming medical conference.
Lilly and BI say Empa-Kidney is the largest study of an SGLT2 inhibitor in chronic kidney disease to date, enrolling more than 6,600 patients. What’s more, the study is targeting adults with CKD who are “frequently seen in clinical practice but who have been under-represented in previous SGLT2 inhibitor trials, therefore addressing a critical unmet need.”
The trial enrolled people with mildly to severe reduced eGFR, a measure of kidney function, as well as people with normal and increased levels of albumin—a type of protein present in the urine. Investigators also enrolled people with and without diabetes, plus those with CKD “attributable to a wide range of underlying causes,” Lilly and BI said.
In the U.S., kidney disease is estimated to affect about 37 million people. The disease is a leading cause of death globally and doubles a person’s risk for hospitalization. Meanwhile, CKD is closely linked with several metabolic and cardiovascular diseases, Lilly and BI point out: Thirty-seven percent of adults with diabetes, 32% of adults with high blood pressure and 18% of adults with obesity also have chronic kidney disease.
Meanwhile, as Jardiance cruises ahead in CKD, the drug has widened its heart failure indications on both sides of the Atlantic. In late February, the FDA signed off on a Jardiance label expansion to curb the risk of cardiovascular death and hospitalization in adults with heart failure. The green light builds on an approval to reduce the risk of hospitalization and death in patients with heart failure and low ejection fraction. February’s approval made Jardiance the only med cleared to improve outcomes in all heart failure patients, no matter their ejection fraction status.
And in March, Jardiance became the first SGLT2 med cleared in Europe to treat all adults with symptomatic chronic heart failure. Echoing its U.S. nod, the drug can now be used in patients with heart failure with preserved ejection fraction (HFpEF), as well as heart failure patients with reduced ejection fraction (HFrEF).
By 2021’s midpoint, Jardiance sales rose 17.2% to 1.4 billion euros (about $1.53 billion), Boehringer Ingelheim said in a half-year earnings report published in August. Stateside, Lilly racked up Jardiance sales of $1.49 billion for all of 2021.
If approved in CKD, Jardiance would have to jockey for space alongside AstraZeneca's SGLT2 rival Farxiga, which won an approval last April to treat chronic kidney disease even in patients without diabetes. It would also have to contend—at least in part—with Johnson & Johnson’s own SGLT2 challenger, Invokana, which boasts an approval in diabetic kidney disease but not in kidney disease patients without diabetes.