The FINANCIAL — Boehringer Ingelheim and Eli Lilly and Company on June 12 announced to conduct a new, large clinical outcomes trial investigating empagliflozin for the treatment of people with chronic kidney disease.
The trial is planned to enroll approximately 5,000 people with chronic kidney disease both with and without type 2 diabetes.
“Our plans for this new trial are yet another example of our ongoing commitment to improving patient health, especially in areas where unmet needs exist,” said Professor Hans-Juergen Woerle, Global Vice President Medicine, Boehringer Ingelheim. “We look forward to exploring the potential that empagliflozin may offer for people with chronic kidney disease.”
Jardiance (empagliflozin) is the first type 2 diabetes medicine to have data on the reduction of the risk of cardiovascular death included in the label in several countries. The EMPA-REG OUTCOME trial demonstrated that empagliflozin reduced the risk of cardiovascular death by 38 percent versus placebo in people with type 2 diabetes and established cardiovascular disease when added to standard of care (including glucose-lowering agents and cardiovascular drugs). As one of the secondary endpoints this trial also showed that empagliflozin reduced the relative risk for new-onset or worsening of kidney disease by 39 percent versus placebo. Based on these results the Boehringer Ingelheim and Lilly Diabetes Alliance decided to formally investigate the potential of empagliflozin in people with chronic kidney disease. This outcome trial together with ongoing mechanistic studies will allow us to further explore the potential mechanisms – including the reduction in glomerular pressure – by which empagliflozin may impact renal outcomes in chronic kidney disease, according to Boehringer Ingelheim.
“More than 10 percent of people worldwide are affected by chronic kidney disease. Its prevalence and severity markedly influence the prognosis and quality of life of patients,” said Professor Christoph Wanner, Chief of the Division of Nephrology and Hypertension at the University Hospital of Wuerzburg, Germany. “New treatments that may have the potential to help address this crucial medical need are desperately needed.”
“Based on the cardiovascular and renal results of the EMPA-REG OUTCOME trial, we along with Boehringer Ingelheim look forward to starting this new trial to gather evidence in support of a potential new indication for empagliflozin in people with chronic kidney disease,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly Diabetes.
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