German pharmaceutical and life sciences company Bayer AG (ETR:BAYN) (OTC:BAYRY) said on Thursday that the US Food and Drug Administration (FDA) has approved Kerendia (finerenone) to reduce urinary albumin-to-creatinine ratio in adults with chronic kidney disease associated with type 1 diabetes.

The company said the approval makes Kerendia the first new treatment in more than 30 years for adults with this condition and is expected to reduce the risk of sustained estimated glomerular filtration rate decline and end-stage kidney disease.

The FDA's decision was supported by the Phase III FINE-ONE trial involving 242 adults, alongside data from the FIDELIO-DKD and FIGARO-DKD trials in patients with type 2 diabetes. In the trial, Kerendia reduced urinary albumin-to-creatinine ratio versus placebo by 22% at three months and 28% at six months.

Bayer said safety and tolerability in FINE-ONE were consistent with existing evidence for Kerendia in chronic kidney disease associated with type 2 diabetes.

Treatment-emergent adverse events occurred in 47.1% of Kerendia patients and 49.2% of placebo patients, while hyperkalemia occurred in 10.1% and 3.3%, respectively.