Bayers Kerendia gets updated label in US to include findings from phase III FIGARO DKD cardiovascular outcomes study

Bayers Kerendia gets updated label in US to include findings from phase III FIGARO DKD cardiovascular outcomes study

By, Admin 5 September 2022

Bayer announced that it received approval from the US Food and Drug Administration (FDA) for a label update for Kerendia (finerenone) to include findings from the phase III FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). The positive data from the pivotal phase III FIGARO-DKD study demonstrated that finerenone significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D. Results from the trial were presented at ESC Congress 2021, and simultaneously published in the New England Journal of Medicine. Patients living with chronic kidney disease associated with type 2 diabetes are three times more likely to die from a cardiovascular event than those with type 2 diabetes alone. FIGARO-DKD is the first contemporary phase III CV outcomes trial to show CV benefit in a patient population where the majority of patients was in earlier CKD stages (stages 1-2 CKD, defined as estimated glomerular filtration rate [eGFR] =60 ml/min/1.73m2) with albuminuria. With the addition of these study findings, the US label now includes clinical trial data from more than 13,000 patients with CKD associated with T2D based on FIDELIO-DKD and FIGARO-DKD.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!