New Interim, Real-World Data Provides Additional Insights on Hyperkalemia and Safety of Kerendia® (finerenone) for Patients with Chronic Kidney Disease Associated with Type 2 Diabetes
New Kerendia™ (finerenone) data show impact of early albuminuria reduction in patients with chronic kidney disease and type 2 diabetes
New Human Biomarker Findings Support Mechanism of Action of Kerendia® (finerenone) in Patients with Chronic Kidney Disease Associated with Type 2 Diabetes
WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer announced it is further investing in MOONRAKER— its clinical development program to investigate Kerendia® (finerenone) as a potential treatment for heart failure (HF) — with the initiation of three additional investigator-sponsored collaborative studies.1,2,3,4 Recruiting approximately 15,000 patients, MOONRAKER is expected to be one of the largest heart failure (HF) study programs to date.1,2,3,4
WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer’s Kerendia® (finerenone) was included in the European Society of Cardiology’s (ESC) latest clinical guidance for patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
AURORA, CO / ACCESSWIRE / August 24, 2023 / CPC Clinical Research today announced the launch of the MOONRAKER Program, a program consisting of 3 randomized trials to evaluate the role of finerenone (KERENDIA®) as a foundational treatment for patients with heart failure. MOONRAKER is designed to support and expand the evidence base for finerenone along with the ongoing pivotal FINEARTS-HF trial (NCT04435626).
WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer announced today the initiation of FINE-ONE, a global, multicenter, randomized, placebo-controlled, double-blind, parallel-group Phase III study to evaluate the efficacy and safety of a new investigational use of finerenone versus placebo in adults with chronic kidney disease (CKD) and type 1 diabetes (T1D). The primary objective of the study is to demonstrate efficacy of finerenone over placebo in reducing urine albumin to creatinine ratio (UACR) over 6 months.
Berlin, June 15, 2023 – Bayer will present new cardiorenal data from the comprehensive Kerendia™ (finerenone) clinical trial program in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) at the 60th European Renal Association (ERA) congress 2023. This new data will include further insights from the FIDELITY prespecified pooled analysis on CKD progression, as well as new findings from the REKA and FINEGUST studies.
Bayer announced that the Chinese National Medical Products Administration (NMPA) granted marketing authorization for a label extension for Kerendia (finerenone) to include results on cardiovascular (CV) outcomes from the phase III FIGARO-DKD study. The study demonstrated that Kerendia reduced the risk of CV events in a broad population of patients with stages 1-4 CKD and T2D. Kerendia (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor antagonist, is now indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adult patients with CKD associated with T2D (with albuminuria).
Berlin, May 17, 2023 – Bayer announced today that the Chinese National Medical Products Administration (NMPA) granted marketing authorization for a label extension for Kerendia™ (finerenone) to include results on cardiovascular (CV) outcomes from the Phase III FIGARO-DKD study. The study demonstrated that Kerendia reduced the risk of CV events in a broad population of patients with stages 1-4 CKD and T2D. Kerendia (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor antagonist, is now indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adult patients with CKD associated with T2D (with albuminuria).