EU clears Lilly, Boehringer's Jardiance for chronic kidney disease

25 Jul 2023
firstwordpharma.com
Phase 3Drug ApprovalClinical ResultAHA
The European Commission on Tuesday announced the approval of Eli Lilly and Boehringer Ingelheim's SGLT2 inhibitor Jardiance (empagliflozin)SGLT2 inhibitor Jardiance (empagliflozin) for adults with chronic kidney disease (CKD). According to the companies, the approval has the potential to advance the standard of care for more than 47 million people living with CKD in the EU, while helping to relieve the burden on healthcare systems by reducing the risk of all-cause hospitalisations for these patients.
Leonard Glass, senior vice president for diabetes and obesity global medical affairs at Eli Lilly, said "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."
The approval is based on results from the Phase III EMPA-KIDNEY trial, which included over 6600 patients, many with co-morbidities across the spectrum of cardiovascular (CV), kidney or metabolic conditions. Results demonstrated that once-daily oral Jardiance significantly cut the risk of kidney disease progression or CV death by 28% versus placebo in adults with CKD. The study also showed a statistically significant relative risk reduction in hospitalisations for any cause by 14% compared to placebo. The overall safety data were generally consistent with previous findings for the drug.
Jardiance, which generated sales of $577.5 million in the first quarter, is currently approved in the EU to treat adults whose type 2 diabetes is not adequately controlled. It is also prescribed for use in adults to treat symptoms of long-term heart failure. Meanwhile, AstraZeneca's SGLT2 inhibitor Forxiga (dapagliflozin), which brought in first-quarter revenues of $1.3 billion, is cleared in the EU to treat type 2 diabetes, chronic heart failure and CKD.
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