Jardiance cleared in EU for CKD, challenging Forxiga

Boehringer Ingelheim and Eli Lilly's SGLT2 inhibitor Jardiance has been approved for chronic kidney disease in the EU - the first major market to clear the new use for the drug.

Adding CKD to the label for Jardiance (empagliflozin) adds to earlier approvals for type 2 diabetes and heart failure, and means that Boehringer and Lilly can now compete head to head across all three indications with AstraZeneca's Forxiga (dapagliflozin).

AZ's drug was approved for CKD in the EU and US in 2021, helping it to post a near-50% increase in sales for the drug last year to almost $4.4 billion.

Boehringer and Lilly's drug is already the market leader, with sales of around $6.1 billion, and approval in CKD will help them fend off the challenge from AZ's fast-growing rival. The two companies also filed for approval of Jardiance in the US in January, with a decision expected from the FDA in the second half of this year.

In a statement, Boehringer and Lilly said Jardiance is the first drug in the SGLT2 inhibitor class to achieve a statistically significant reduction in all-cause hospitalisations compared to placebo, helping to reduce the burden of the disease on healthcare systems. Hospitalisations account for up to 70% of total healthcare costs for people with CKD, according to EU data.

Leonard Glass, senior vice president for diabetes and obesity global medical affairs at Eli Lilly, remarked that "CKD is closely linked to other cardio-renal-metabolic conditions, such as type 2 diabetes and heart failure – thus, an integrated approach is vital for optimised treatment of these interconnected conditions."

Approval by the European Commission makes Jardiance an option for approximately 47 million people in the EU who are living with CKD, according to a joint statement from Boehringer and Lilly. However, many of them are not aware they have the condition, as it is difficult to diagnose.

The approval is based on results from EMPA-KIDNEY, billed as the largest and broadest dedicated SGLT2 inhibitor trial in CKD to date, which showed a significant benefit of Jardiance in reducing the relative risk of kidney disease progression or cardiovascular death by 28% compared to placebo.

The trial also revealed a significant relative risk reduction in hospitalisation for any cause by 14% versus placebo. EMPA-KIDNEY was stopped early last year after an independent monitoring panel found the drug's benefit to be proven, and that withholding treatment from the placebo group was no longer ethical.

For comparison, Forxiga (known as Farxiga in the US) was shown in the DAPA-CKD to cut by 39% the risk of kidney disease progression, or death from kidney or cardiovascular causes.

The new approval comes shortly after Jardiance became the first SGLT2 drug to be approved by the FDA in children 10 years and older with type 2 diabetes.