Bayer to present new cardiorenal data from comprehensive Kerendia ™( finerenone) clinical trial program across a broad range of cases with habitual order complaint and type 2 diabetes
dedication Late- breaking data from pooled,post-hoc analysis will give new perceptivity into the efficacity and safety of Kerendia in cases with habitual order complaint( CKD) and type 2 diabetes( T2D) who have sustained an acute change in estimated glomerular filtration rate( eGFR)/ FIDELIO- DKDPost-hoc analysis explored the cardiorenal goods of Kerendia in cases with CKD and T2D from Asia/ FIDELIO- DKD Group analysis estimated the efficacity and safety of Kerendia in cases with CKD and T2D from China/ FINE- REAL Study design of the first prospective experimental study of cases with CKD and T2D treated with Kerendia
Bayer will present new renal and cardiovascular( CV) data from the comprehensive Kerendia ™( finerenone) clinical trial program in cases with habitual order complaint( CKD) and type 2 diabetes( T2D) at the American Society of Nephrology’s( ASN) order Week 2022, from 1- 6 November. Four new sets of data will be presented including a late- breaking pooled,post-hoc analysis of FIDELITY, farther analyses of FIDELIO- DKD, and the design of the first prospective experimental study, FINE-REAL.
Kerendia FIDELITY study data
The prespecified pooled analysis FIDELITY, including the FIDELIO- DKD and FIGARO- DKD studies, comprises data in>,000 cases with CKD and T2D. dedication delved the efficacity and safety of Kerendia across a broad range of cases with early to late- stage CKD and T2D, and handed perceptivity into the relationship between CKD stage( grounded on birth order complaint perfecting Global issues – KDIGO – threat orders) and the goods of Kerendia on compound CV and order-specific endpoints.
About Kerendia ™( finerenone)
Kerendia is anon-steroidal, picky mineralocorticoid receptor( MR) antagonist that has been shown to block dangerous goods of MR overactivation. MR overactivation contributes to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or seditious and fibrotic factors.
Grounded on the positive results of the FIDELIO- DKD Phase III study, Kerendia ™ was granted marketing authorization by theU.S. Food and Drug Administration( FDA) in July 2021, the European Commission in February 2022, and the Chinese National Medical Products Administration( NMPA) in June 2022. In September 2022, Bayer blazoned that it entered blessing from theU.S. FDA for a marker update for Kerendia ™ to include findings from the Phase III FIGARO- DKD CV issues study. In March 2022, Bayer submitted a Type II Variation operation grounded on the data from FIGARO- DKD to the European Medicines Agency( EMA) to seek an extension of the marketing authorization for Kerendia ™ to include early stages of CKD associated with T2D. Grounded on the positive results of both vital Phase III studies, FIDELIO- DKD and FIGARO- DKD, Kerendia ™ was approved in March 2022 by the Japanese Ministry of Health, Labour, and Welfare( MHLW). farther nonsupervisory blessings by other health authorities in multiple other countries have been granted or are presently pending following cessions for marketing authorization.
The Phase III study programme with finerenone, FINEOVATE, presently comprises five Phase III studies, FIDELIO- DKD, FIGARO- DKD, FINEARTS- HF, FIND- CKD, and FIONA, as well as the Phase II study CONFIDENCE.
About habitual order complaint in Type 2 Diabetes
habitual order complaint( CKD) is a common and potentially deadly condition that’s extensively underrecognized. CKD progresses quietly and unpredictably, with numerous symptoms not appearing until the complaint is well- advanced. CKD is one of the most frequent complications arising from diabetes and is also an independent threat factor of cardiovascular complaint. Up to 40 of all cases with type 2 diabetes develop habitual order complaint. Despite guideline- directed curatives, cases with CKD and T2D remain at high threat of CKD progression and cardiovascular events. It’s estimated that CKD affects further than 160 million people with T2D worldwide. habitual order complaint in type 2 diabetes is the main cause of end stage order complaint, which requires dialysis or a order transplant to stay alive. Cases with habitual order complaint and type 2 diabetes are three times more likely to die from a cardiovascular-affiliated cause than those with type 2 diabetes alone.
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