Jardiance (Epagliflozin) was approved by EU for chronic kidney disease in adults
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Jardiance (Epagliflozin) was approved by EU for chronic kidney disease in adults.
Good news for CKD patients: Jardiance (Epagliflozin) was approved by the European Union for the treatment of chronic kidney disease in adults.
Potential to improve the standard of care for more than 47 million CKD patients in the EU.
On July 28th, Boehringer Ingelheim and Eli Lilly announced that the European Commission (EC) has approved the use of Jardiance® (empagliflozin) for the treatment of adults with chronic kidney disease (CKD).
This approval is expected to elevate the standard of care for over 47 million CKD patients in the European Union and help reduce the overall hospitalization rates among CKD patients, thereby alleviating the burden on healthcare systems.
In addition to its existing indications for type 2 diabetes and heart failure, empagliflozin will now aid in managing the risks associated with cardiorenal-metabolic diseases, which frequently interrelate and affect over 1 billion people globally.
The approval was based on the results of the EMPA-KIDNEY trial, the largest and most extensive SGLT2 inhibitor trial conducted to date for CKD.
The trial demonstrated that empagliflozin significantly benefits patients with chronic kidney disease, reducing the relative risk of kidney disease progression or cardiovascular death by 28% compared to a placebo (HR: 0.72; 95% CI 0.64-0.82; P < 0.000001 [absolute risk reduction 3.8%]).
The trial also showed that empagliflozin lowers the relative risk of hospitalization for any reason by 14% compared to a placebo, with statistical significance (HR: 0.86; 95% CI 0.78-0.95; P = 0.0025 [absolute risk reduction 4.4%]).
The overall safety data from the trial remained consistent with previous research, confirming the safety profile of empagliflozin.
CKD doubles the individual risk of hospitalization and is a leading cause of global mortality. In the European Union, hospitalizations account for 70% of the total healthcare costs for CKD patients.
About Empagliflozin
Empagliflozin (trade name Outantisine®) is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor and the first to be approved in many countries.
Type 2 diabetes drug with labeling containing data on reduction in risk of cardiovascular death in patients with type 2 diabetes and cardiovascular disease.
In the EU, Empagliflozin is indicated for adults with type 2 diabetes, heart failure, and most recently for chronic kidney disease.
Jardiance (Epagliflozin) was approved by EU for chronic kidney disease in adults
(source:internet, reference only)
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