Positive CHMP opinion recommending SGLT2 inhibitor for treatment of CKD
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion on the recommendation the SGLT2 inhibitor empagliflozin for the treatment of adults with CKD. This CHMP recommendation is based on the results of the EMPA-KIDNEY trial.
The EMPA-KIDNEY phase III trial -a multinational randomized, double-blind, placebo-controlled, clinical trial- included 6609 adults with established CKD both with and without diabetes, as well as with and without albuminuria. Results showed that empagliflozin provided kidney and CV benefit by reducing the time to a first event of CV death or kidney disease progression or CV death with 28% compared with placebo.
Empagliflozin is now approved for the treatment of type 2 diabetes and heart failure.