Not for U.S. and UK Media
Bayer made a groundbreaking announcement today, revealing that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion. They are recommending a label extension for Kerendia™ (finerenone, 10 mg or 20 mg) to include results on cardiovascular outcomes from the Phase III FIGARO-DKD study. The study showed that finerenone reduced the risk of cardiovascular events in a broad population of patients with stages 1-4 CKD and T2D. The CHMP recommended the approval of the extension of the indication of Kerendia™ (10 mg or 20 mg) to early stages* of CKD associated with T2D: “Kerendia is indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults. For study results with respect to renal and cardiovascular events, see section 5.1.” The final decision by the European Commission, authorizing marketing approval in the European Union, is expected early in 2023.
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 in addition to standard of care on the reduction of CV morbidity and mortality in approximately 7,400 patients with CKD and T2D. The positive data from FIGARO-DKD demonstrated that finerenone significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D.
“As patients are faced with an increased risk of cardiovascular events already in early stages of chronic kidney disease and type 2 diabetes, and as this risk is growing with kidney health decline, timely diagnosis and treatment is crucial to limit disease progression and to potentially prevent cardiovascular complications and mortality,” said Professor Peter Rossing, Head of Complications Research at the Steno Diabetes Center Copenhagen. “FIGARO-DKD is the first contemporary Phase III cardiovascular outcomes trial to show cardiovascular benefit in patients with chronic kidney disease and type 2 diabetes where the majority of the population were in earlier stages* with albuminuria.”
Mineralocorticoid receptor (MR) overactivation contributes to CKD progression and CV damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors. Highlighting an alternative pathway, Kerendia offers protection as it selectively binds to the MR receptor, blocking harmful effects of MR overactivation.
“Patients with chronic kidney disease and type 2 diabetes are three times more likely to die from a cardiovascular event than those with type 2 diabetes alone. These patients are in need of treatment options that can both delay kidney disease progression and reduce the risk of cardiovascular events,” said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. “At Bayer, we are committed to providing treatment options that offer clinically meaningful benefits for patients. The recommendation from the CHMP to extend the label underlines Kerendia as a distinctive treatment option that has demonstrated kidney and cardiovascular benefits in a broad patient population with chronic kidney disease and type 2 diabetes.”
In October,
