Source – Boehringer Ingelheim
The European Union has granted approval for Boehringer Ingelheim and Eli Lilly’s SGLT2 inhibitor, Jardiance (empagliflozin), to be used in chronic kidney disease (CKD), making it the first major market to clear this new indication for the drug.
With the addition of CKD to its label, Jardiance now holds approvals for type 2 diabetes and heart failure as well. This means that Boehringer and Lilly can now directly compete with AstraZeneca’s Forxiga (dapagliflozin) in all three indications.
Forxiga received approval for CKD in both the EU and the US in 2021, contributing to a nearly 50% increase in sales for the drug last year, totaling almost $4.4 billion.
“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 optimized treatment of these interconnected conditions. We look forward to continuing conversations with other regulatory bodies worldwide so that empagliflozin can be made available for as many people living with these conditions as quickly as possible.”
– Leonard Glass, M.D., F.A.C.E., senior vice president, Diabetes & Obesity Global Medical Affairs, Lilly.
However, despite AstraZeneca’s success, Jardiance is already the market leader, generating sales of approximately $6.1 billion. The approval for CKD will aid Boehringer and Lilly in defending their position against the challenge posed by AstraZeneca’s fast-growing rival. Both companies have also sought approval for Jardiance in the US, and a decision from the FDA is anticipated in the second half of the year.
According to Boehringer and Lilly, Jardiance is the first drug in the SGLT2 inhibitor class to demonstrate a statistically significant reduction in all-cause hospitalizations compared to placebo. This reduction in hospitalizations can help alleviate the burden of the disease on healthcare systems, as hospitalizations account for up to 70% of total healthcare costs for people with CKD, as per EU data.
“We celebrate this significant milestone in the field of chronic kidney disease. CKD is a silent killer and prevention and early detection are crucial in the general population. This new treatment option has the potential to further improve the management of cardiorenal metabolic syndrome and renal disease, offering renewed hope and improved quality of life for countless individuals living with CKD worldwide.”
– Daniel Gallego, President of European Kidney Patients’ Federation
Leonard Glass, senior vice president for diabetes and obesity global medical affairs at Eli Lilly, emphasized the interconnected nature of CKD with other cardio-renal-metabolic conditions, such as type 2 diabetes and heart failure, emphasizing the importance of an integrated approach for optimal treatment.
With European Commission approval, Jardiance becomes an available treatment option for about 47 million people in the EU who are living with CKD. However, many of them may not be aware of their condition due to difficulties in diagnosis.
The approval is based on the results of the EMPA-KIDNEY trial, which is considered the largest and most comprehensive dedicated SGLT2 inhibitor trial in CKD to date. The study demonstrated a significant benefit of Jardiance in reducing the relative risk of kidney disease progression or cardiovascular death by 28% compared to placebo. Moreover, it revealed a significant relative risk reduction of 14% in hospitalizations for any cause compared to placebo.
Notably, EMPA-KIDNEY was stopped early after an independent monitoring panel confirmed the drug’s efficacy, deeming it unethical to withhold treatment from the placebo group.
For comparison, Forxiga (Farxiga in the US) was shown in the DAPA-CKD trial to reduce the risk of kidney disease progression or death from kidney or cardiovascular causes by 39%.
In addition to the CKD approval, Jardiance has also become the first SGLT2 drug to be approved by the FDA for use in children aged 10 years and older with type 2 diabetes.
