2022-11-07| Trials & Approvals

Eli Lilly and BI Notch Clinical Win for Kidney Disease Drug

by Reed Slater
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In a heated rivalry with AstraZeneca’s Farxiga, Eli Lilly and Boehringer Ingelheim (BI) posted positive results from a Phase 3 trial evaluating the safety and efficacy of Jardiance in patients with chronic kidney disease (CKD). The data could push Jardiance to its fourth indication, putting it in direct competition with Farxiga.

A Huge Clinical Trial to Fortify the Data

Eli Lilly and BI touted the EMPA-KIDNEY Phase 3 clinical trial as the biggest SGLT2 inhibitor trial to date. The trial included 6,609 participants from what the companies described as the broadest range of CKD patients ever. 

The massive pool of participants responded well to Jardiance, with the risk of kidney disease progression or cardiovascular death reduced by 28% compared to the placebo. The study also met a secondary endpoint by reducing all-cause hospitalizations by 14%. 

Jeff Emmick, M.D., Ph.D., vice president of product development at Eli Lilly, said, “Today’s EMPA-KIDNEY trial results will be welcomed by people living with CKD and the medical community. We are also encouraged by the risk reduction for hospitalization after just two years, as this finding is in line with the significant reductions seen in prior Jardiance cardiovascular outcomes trials. The Alliance looks forward to discussing plans for marketing authorization for CKD with regulators worldwide in due course.”

A CKD approval would heat the competition between it and AstraZeneca’s Farxiga, which received approval to treat CKD in April last year. 

Related Article: AstraZeneca’s Treatment for Chronic Kidney Disease Wins Yet Another Approval

Jockeying for the Industry-Leading SGLT2 Inhibitor

Always a few steps behind Farxiga, Jardiance is picking up speed to stay competitive with AstraZeneca’s blockbuster. With CKD approval, Jardiance would have nearly all of the same indications as Farxiga, providing consumers with two high-quality choices for various kidney and heart-related diseases. 

The two drugs have always been neck and neck in the race for approvals. In January 2014, Farxiga notched its first approval to treat type 2 diabetes. In August of the same year, Jardiance followed suit. In December 2016, the FDA approved Jardiance to reduce cardiovascular death in adults with type 2 diabetes. Farxiga countered a few years later, in 2019, with approval to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes. 

In May 2020, the FDA approved Farxiga to treat heart failure in patients with reduced ejection fraction. Jardiance saw the approval as a challenge. After gaining the same approval in August last year, Jardiance received approval to treat heart failure regardless of left ventricular ejection fraction in February this year.

According to Eli Lilly’s third-quarter results, Jardiance brought in $573 million, a 47% increase over last year. AstraZeneca will post third-quarter results on November 10, but last year, Farxiga raked in $3 billion, a 53% increase over 2020.

The most recent Phase 3 clinical trial data sets the stage for Jardiance’s hopeful CKD approval, deepening the competition between it and Farxiga. Time will tell, but 2023 may see two heavy-hitting SGLT2 inhibitors on the market to treat CKD for many needy patients. 

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