Category: finerenone
Bayer has claimed EU approval for Kerendia, its new drug for chronic kidney disease (CKD) in people with type 2 diabetes, as the company tries to build a role of the drug alongside rival therapies from AstraZeneca and Johnson & Johnson. The approval is based on the phase 3 FIDELIO-DKD trial, in which Kerendia (finerenone) […]
Bayer’s big investment in time and money on the development of finerenone for chronic kidney disease (CKD) in diabetics has paid off with an FDA approval, although it could face stiff competition in the market. The oral, non-steroidal mineralocorticoid receptor (MR) antagonist has been approved as Kerendia in the US – its first world market […]
Shots: The approval is based on a P-III FIDELIO-DKD study evaluating finerenone (10/20mg) + SoC vs PBO + SoC in ~ 5700 patients with CKD & T2D. Patients were followed for a median of 2.6yrs. Results: reduction in the incidence of the primary composite EPs of a sustained decline in eGFR of ≥40%, reduction in […]
Shots: The P-III FIGARO-DKD study involves assessing the efficacy and safety of finerenone (10/20mg, PO, qd) + SoC vs PBO + SoC in ~7400 patients with CKD and T2D at 1,000+ sites across 47 countries globally The study resulted in meeting its 1EPs i.e reduction in the composite risk of time to the first occurrence […]
Shots: The P-III FIDELIO-DKD study in CKD and T2D enrolled over 13,000 patients with early kidney damage and more advanced stages of kidney disease. The data were presented at the ASN Kidney Week 2020 and published in the NEJM based on which Bayer submitted finerenone for marketing authorization in the US and the EU Results: […]
Shots: The MAA submitted to the EMA and the NDA to the US is based on P-III FIDELIO-DKD study assessing finerenone (10/20mg, qd) + SOC vs PBO in ~5,700 patients with CKD and T2D Result: reduction in the combined risk of time to kidney failure; a decrease of eGFR (≥ 40%) from baseline @4wks. or […]
Bayer’s blockbuster ambitions for diabetic kidney disease (DKD) drug candidate finerenone look a lot firmer with the publication of data from the phase 3 FIDELIO-DKD trial. Bayer teased the top-line result from the study back in July, providing the first clue that its sizeable investment in the finerenone programme could pay off, but kept the […]