MHRA authorisation of new treatment for chronic kidney disease associated with diabetes
pharmafile | March 9, 2022 | News story | Research and Development |
The MHRA has authorised the use of Kerendia® (finerenone) (10mg or 20mg), an oral, first-in-class non-steroidal, selective mineralocorticoid receptor (MR) antagonist, for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults. This makes finerenone the only drug developed exclusively for CKD eligible to adults in the UK living with chronic kidney disease associated with type 2 diabetes (T2D).
In spite of guideline-directed therapies, many patients with CKD associated with T2D progress to kidney failure or premature death.
Chronic kidney disease associated with type 2 diabetes is the most common cause of kidney failure and often leads to patients requiring dialysis or a kidney transplant to stay alive,” shared Professor David Wheeler, Professor of Kidney Medicine at University College London and Honorary Consultant Nephrologist at the Royal Free London NHS Foundation Trust “There remains a critical medical need to protect these patients by delaying kidney disease progression and reducing their risk of cardiovascular events, which is why this is welcoming news for patients living with the condition. Physicians in the UK now have another new treatment option to help improve kidney outcomes in this patient population.”
The authorisation is based on results from the Phase III FIDELIO-DKD study, investigating the efficacy and safety of finerenone on kidney and cardiovascular outcomes in 5,734 adult patients with CKD associated with type 2 diabetes.
Dr. Antonio Payano, Senior Bayer Representative, Head of Pharmaceuticals at Bayer UK & Ireland, commented: “Chronic kidney disease associated with type 2 diabetes not only ultimately has a debilitating impact on patients’ lives, but managing end-stage kidney disease consequently also places a huge financial burden on the already stretched NHS services. Timely detection and management are therefore vital to ensure the best outcomes for patients and that kidney health is carefully monitored in those at-risk. We believe the availability of finerenone provides UK physicians with a much-needed new management option to help alleviate the huge burden of chronic kidney disease on patients and the healthcare system.”
Ana Ovey
