Expanded EU Approval: Kerendia™ Now Available for a Wide Range of Chronic Kidney Disease and Type 2 Diabetes Patients

Exciting News: Kerendia™ (finerenone) Granted Expanded Indication in the EU!

Berlin, February 10, 2023 – We’re thrilled to announce that the European Commission has approved a label extension for Kerendia™ (finerenone) in the European Union (EU). This extension includes incredible results on cardiovascular (CV) outcomes from the Phase III FIGARO-DKD study. The study showed that Kerendia reduced the risk of CV events in a broad population of patients with stages 1-4 CKD and T2D. In addition to this groundbreaking news, Kerendia is now indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults. What an incredible development for patients and healthcare providers alike!

Even better, the results from the pivotal Phase III FIGARO-DKD study were presented at the European Society of Cardiology (ESC) Congress 2021 and simultaneously published in the New England Journal of Medicine. FIGARO-DKD investigated the efficacy and safety of finerenone versus placebo, and the positive data demonstrated that finerenone significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D versus placebo.

According to Professor Peter Rossing, Head of Complications Research at the Steno Diabetes Center Copenhagen, “patients with type 2 diabetes should be regularly monitored by their doctor for the earliest signs of kidney disease, and once diagnosed should be treated comprehensively to reduce the risk of cardiovascular complications and death.” This is such an important step forward in improving patient care and outcomes.

We’re also excited to share that Kerendia offers protection as it selectively binds to the MR receptor, blocking harmful effects of MR overactivation. Dr. Michael Devoy, Chief Medical Officer of Bayer Pharmaceuticals Division, explains, “Kerendia addresses a key cause of disease progression that is not addressed by other therapies, and offers physicians a distinct path to protect patients from further kidney damage and cardiovascular events.” What a game-changer!

So what’s next? Based on the positive results of the FIDELIO-DKD Phase III study, Kerendia was granted initial marketing authorization by the European Commission in February 2022 for the treatment of CKD (stage 3 and 4 with albuminuria) associated with T2D in adults. We can’t wait to see how this incredible innovation continues to positively impact the lives of patients. Read More

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