With an FDA approval 19 months ago to treat chronic kidney disease, AstraZeneca’s Farxiga dominated the race against its primary SGLT2 rival—Eli Lilly and Boehringer Ingelheim’s Jardiance. And since then, AZ has reaped the rewards as Farxiga has produced hefty sales increases.
But on Friday, Lilly and BI clapped back with data from a CKD trial that they referred to as “landmark." The data could help pave the way for a catch-up approval.
In the massive trial of 6,609 participants—trumpeted as the largest and broadest for an SGLT2 inhibitor—Jardiance nailed its primary endpoint by reducing kidney disease progression or cardiovascular death by 28% versus placebo. It also had a key secondary endpoint victory, showing a 14% reduction in hospitalization for any cause.
Despite those wins, other key secondary endpoints—such as hospitalization for heart failure, cardiovascular death or all-cause death—were not met. But the ability to detect these was limited by the number of events observed, the companies said.
Investigators revealed the results during the American Society of Nephrology’s (ASN) Kidney Week.
The findings are particularly significant, the companies said, because the trial included a broad range of CKD patients and showed across-the-board success in the effectiveness of Jardiance.
“Previous SGLT2 inhibitor trials focused on certain groups of people living with CKD, such as those with diabetes or high levels of protein in their urine,” Oxford professor Richard Haynes, the trial’s co-principal investigator, said in a release.
Lilly said it will discuss the results with regulators around the world to pursue marketing authorization.
Over recent years, top SGLT2 players have been in a race to rack up lucrative approvals. In 2020, AZ's Farxiga gained a landmark FDA blessing to treat heart failure, but the nod was limited to those with reduced ejection fraction.
In February of this year, Jardiance countered when it won an endorsement to treat HF regardless of ejection fraction.
With the label expansions, Farxiga’s sales have improved dramatically, from $2 billion in 2020 to $3 billion in 2021. Through the first half of this year, AZ reported sales of $2.1 billion. Meanwhile, in 2021, BI recorded Jardiance sales of 3.9 billion euros ($4.3 billion), a 29% increase from the previous year.