Data from FIDELITY, a prespecified pooled analysis of the Phase III FIDELIO-DKD and FIGARO-DKD studies, highlight the potential of Kerendia™ (finerenone) to reduce the incidence of sudden cardiac death / While in the overall FIDELITY population, the effect of finerenone on all-cause and CV mortality narrowly missed statistical significance, new data from a prespecified on-treatment analysis from FIDELITY indicate that both of these outcomes were reduced with finerenone versus placebo in this population / Patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) are approximately three times more likely to die from a cardiovascular-related cause than those with T2D alone
Late- breaking data presented moment at the European Society of Cardiology Congress 2022 punctuate the eventuality of Kerendia ™( finerenone), compared to placebo, to significantly reduce the prevalence of unforeseen cardiac death across a broad range of cases with early to late- stage habitual order complaint( CKD) and type 2 diabetes( T2D).
While in the overall population of FIDELITY the effect of finerenone on all- cause and CV mortality hardly missed statistical significance, new data from a prespecified exploratory on- treatment analysis from FIDELITY indicate that both of these issues were reduced with finerenone versus placebo in this population. The positive effect of finerenone on all mortality issues was harmonious across a broad range of cases with early to late- stage habitual order complaint and type 2 diabetes, anyhow of birth eGFR or UACR values, and appeared to be more pronounced in cases with a advanced birth eGFR. CV mortality was the most common cause of mortality in the study.
“ habitual order complaint is a common yet extensively underrecognized and potentially deadly condition. habitual order complaint can dock life expectation of cases with diabetes by over to 16 times, relative to the general population living without either complaint, ” said Gerasimos Filippatos,M.D., Professor of Cardiology at the National and Kapodistrian University of Athens, Greece, andco-principal investigator of the FIDELIO- DKD and FIGARO- DKD Phase III clinical trials. “ structure on the growing body of clinical substantiation for finerenone, which demonstrated the benefit of this treatment on renal and cardiovascular issues, these new data punctuate the positive goods of finerenone on morbidity and mortality across a broad range of complaint rigidness in cases with habitual order complaint and type 2 diabetes. ”
“ Despite optimized blood glucose and blood pressure control, numerous cases with habitual order complaint and type 2 diabetes continue to progress to order failure and are at a significantly increased threat of cardiovascular death, ” saidDr. Christian Rommel, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “ The exploratory analysis presented demonstrates the eventuality of finerenone to reduce the threat of mortality amongst this vulnerable patient population, and keep them healthier for longer. ”
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. 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.
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.
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.
About Bayer’s Commitment in Cardiovascular and order conditions
Bayer is an invention leader in the area of cardiovascular conditions, with a long-standing commitment to delivering wisdom for a better life by advancing a portfolio of innovative treatments. The heart and the feathers are nearly linked in health and complaint, and Bayer is working in a wide range of remedial areas on new treatment approaches for cardiovascular and order conditions with high unmet medical requirements. The cardiology ballot at Bayer formerly includes a number of products and several other composites in colorful stages of preclinical and clinical development. Together, these products reflect the company’s approach to exploration, which prioritizes targets and pathways with the eventuality to impact the way that cardiovascular conditions are treated.
Bayer is a global enterprise with core capabilities in the life wisdom fields of health care and nutrition. Its products and services are designed to help people and the earth thrive by supporting sweats to master the major challenges presented by a growing and growing global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and produce value through invention and growth. The Bayer brand stands for trust, trustability and quality throughout the world. In financial 2021, the Group employed around,000 people and had deals of44.1 billion euros.