European Commission approves SGLT2 inhibitor for CKD

News - July 31, 2023

The European Commission approved the SGLT2 inhibitor empagliflozin for the treatment of adults with CKD. This approval expands the indication of empagliflozin, which was previously approved in the EU for the treatment of T2D and HF. The European Commission based their approval on the results of the EMPA-KIDNEY trial.

The EMPA-KIDNEY trial was a multinational randomized, double-blind, placebo-controlled, phase 3 clinical trial in which 6609 patients with CKD were included. Many participants had a variety of co-morbidities across the spectrum of CV, renal or metabolic conditions. In EMPA-KIDNEY, empagliflozin significantly reduced the risk of kidney disease progression or CV death by 28% compared with placebo in patients with CKD. Moreover, empagliflozin reduced the risk for hospitalization for any cause by 14% compared with placebo in patients with CKD.

Source: Press release Boehringer Ingelheim, July 25, 2023

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