EU regulators have approved Bayer's Kerendia (finerenone) to treat adults with chronic kidney disease associated with type 2 diabetes, the company announced Monday. The decision comes on the heels of a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use, and follows FDA approval of the oral drug for the same indication last year.

Michael Devoy, head of medical affairs and pharmacovigilance at Bayer's pharmaceuticals division, said the EU approval of Kerendia "offers physicians a new path to protect these vulnerable patients by reducing their risk of cardiovascular (CV) events and delaying kidney disease progression." Kerendia works by blocking the mineralocorticoid receptor overactivation thought to contribute to CKD progression and CV damage.

Bayer's filing was supported by data from the Phase III FIDELIO-DKD trial, comparing Kerendia to placebo when added to standard care in around 5700 CKD patients with type 2 diabetes. Results showed that significantly fewer patients in the Kerendia group progressed to a composite endpoint that included a minimum 40% reduction in kidney function, onset of kidney failure, or kidney death.

The drug has also succeeded in the Phase III FIGARO-DKD study of CKD patients with type 2 diabetes. Detailed findings unveiled last year showed that Kerendia significantly reduced the risk of the composite primary endpoint of time to first occurrence of CV death or nonfatal CV events by 13% over a median follow-up of 3.4 years when added to ACE inhibitors or angiotensin receptor blockers. Bayer noted that its treatment has also been submitted for marketing authorisation in China and other countries