Shortly after securing European approval for the treatment of chronic kidney disease (CKD), Eli Lilly and Boehringer Ingelheim have achieved a significant milestone by expanding the reach of their versatile SGLT2 inhibitor, Jardiance, in the United States.
On Friday, both companies announced that the FDA has granted approval for Jardiance to be used in the treatment of adult patients with CKD. More specifically, the drug has been approved for the purpose of reducing the risk of sustained decline in the estimated glomerular filtration rate, end-stage kidney disease, cardiovascular death, and hospitalization in adult patients at risk of progression.
This approval enriches the array of treatment options available for approximately 35 million adults in the US who grapple with CKD, marking a significant development. Notably, this achievement follows closely on the heels of the European Commission’s approval of Jardiance for CKD treatment.
In both the European and U.S. contexts, the FDA’s approval is underpinned by the results of the pivotal phase 3 EMPA-KIDNEY trial, which enrolled a substantial cohort of over 6,600 patients. In this clinical study, Jardiance demonstrated an impressive 28% relative risk reduction compared to the placebo group, focusing on the composite primary endpoint involving kidney disease progression or cardiovascular death. It’s worth noting that all participants in the trial also received the standard of care.
This milestone now sets the stage for Jardiance to compete in the CKD space with its class rival. In April 2021, AstraZeneca’s SGLT2 inhibitor, Farxiga, secured FDA approval for the same indication. At that time, AstraZeneca heralded the approval as the “most significant advancement” in CKD treatment in two decades.
Both Jardiance and Farxiga have been achieving robust sales figures in recent times. Boehringer reported an impressive 3.5 billion euros ($3.83 billion) in sales from Jardiance during the first half of the year, while Eli Lilly reported revenues of $1.25 billion from the drug. Although Boehringer did not disclose the precise growth rate for Jardiance, Eli Lilly noted a substantial 42% increase in revenues from the drug compared to the first half of 2022.
AstraZeneca’s Farxiga also posted remarkable financial results, amassing $2.8 billion in revenue during the first half of the current year, marking a significant 39% increase at constant exchange rates. Beyond its CKD indication, Jardiance boasts broad U.S. approvals for the treatment of heart failure and diabetes, reinforcing its position as a versatile and impactful therapeutic option.