New therapeutic option to reduce risk of cardiovascular deaths and repeated hospitalizations among adult heart failure patients approved in Singapore
Over the course of the VICTORIA study,there was a 4.2% reduction in annualized absolute risk with VERQUVO™ (vericiguat) compared with placebo in reducing the risk of cardiovascular death or heart failure (HF) hospitalization in adults with symptomatic chronic HF and ejection fraction less than 45% following a worsening heart failure event.
VERQUVO™ (vericiguat) is the first soluble guanylate cyclase stimulator,a new class of drugs,to treat worsening HF.
HF is extremely prevalent in Singapore. In 2015,4.5% of Singaporeans live with heart failure[1],with the average age of a heart failure patient at 61 years old,about 10 years before Europeans and Americans.
SINGAPORE,May 17,2022 --Bayer's VERQUVO™ (vericiguat),a soluble guanylate cyclase (sGC) stimulator,has been approved in Singapore for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction less than 45%,who are stabilized after a recent decompensation event requiring outpatient intravenous (IV) therapy,with no complications and are not at end-stage heart failure. Vericiguat is administered in combination with other HF therapies to reduce the risk of cardiovascular death and heart failure.[2]
The approval of VERQUVO™ (vericiguat),the first treatment for worsening heart failure approved specifically for patients following a hospitalization for HF or need for outpatient IV diuretics,is based on the results of the pivotal Phase III VICTORIA trial and follows a priority regulatory review.
Chronic HF is a substantial economic and public health burden affecting more than 60 million people worldwide[3]where individuals face a one in five lifetime risk of developing heart failure[4]. HF is extremely prevalent in Singapore. In 2015,about 10 years before Europeans and Americans.[5] The age-adjusted HF admission rose by approximately 40% in the last decade,making HF the most common cardiac cause of hospitalization in Singapore.[6] Following initial diagnosis of heart failure,many patients continue to experience a devastating cycle of escalating symptoms and repeated hospitalizations despite being on optimal current therapies.[7]
Clinical Associate Professor David Sim,Deputy Head and Senior Consultant with the Department of Cardiology,Director of the Heart Failure Programme and Clinical Trials at the National Heart Centre Singapore (NHCS) said,"One in four patients are readmitted for worsening heart failure within 6 months of discharge for decompensated heart failure. The cardiovascular mortality and all-cause mortality are in excess of 10% and 20%,respectively. The approval of new therapeutic option could potentially provide healthcare professionals with the opportunity to optimize patients' therapies and reduce repeated HF hospitalizations."
In VICTORIA,the primary efficacy objective was to determine whether VERQUVO™ (vericiguat) is superior to placebo,both in combination with other heart failure therapies,in reducing the risk of cardiovascular death or heart failure hospitalization in adults with symptomatic chronic heart failure and ejection fraction less than 45% following a worsening heart failure event. VERQUVO™ (vericiguat) met the primary efficacy objective based on a time-to-event analysis (hazard ratio [HR]: 0.90,95% confidence interval [CI],0.82-0.98; p=0.019). Over the course of the study,there was a 4.2% reduction in annualized absolute risk with VERQUVO™ (vericiguat) compared with placebo. Therefore,24 patients would need to be treated over an average of one year to prevent one primary endpoint event.
"The VICTORIA trial,exclusively performed in patients with worsening heart failure,found that the soluble guanylate cyclase stimulator,is effective in reducing hospitalisations in a high-risk population of patients with worsening heart failure and reduced ejection fraction," saidProfessor Carolyn Lam,Senior Consultant at the Department of Cardiology and Director of Women's Heart Health at NHCS,and member of the global steering committee for VICTORIA.
Based on the VICTORIA study,vericiguat is also approved the United States,Japan,Taiwan,Australia and European Union (EU) under the brand name VERQUVO™ (vericiguat). In the EU it is indicated for symptomatic chronic HF in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring IV therapy.
VERQUVO™ (vericiguat) (2.5 mg,5 mg,and 10 mg tablets) is being jointly developed with MSD.
About Verquvo™ (vericiguat)
VERQUVO™ (vericiguat) 2.5 mg,and 10 mg is an oral once daily stimulator of soluble guanylate cyclase (sGC),an important enzyme in the nitric oxide (NO) signaling pathway. When NO binds to sGC,the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP),a second messenger that plays a role in the regulation of vascular tone,cardiac contractility,and cardiac remodeling. Heart failure is associated with impaired synthesis of NO and decreased activity of sGC,which may contribute to myocardial and vascular dysfunction. By directly stimulating sGC,independently of and synergistically with NO,vericiguat augments levels of intracellular cGMP,leading to smooth muscle relaxation and vasodilation.
About Cardiology at Bayer
Bayer is an innovation leader in the area of cardiovascular diseases,with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease,and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds are in various stages of preclinical and clinical development. Together,these products reflect the company's approach to research,which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.
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References
Carolyn S P Lam. Heart Failure in Southeast Asia: facts and numbers,PubMed,June 2015
Singapore Verquvo Prescribing Information,September 2021.
Vos T,et al. A systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017; 390: 211–59
Sarvarese G,et al. Gloval Public Health Burden of Heart Failure. Cardiac Failure Review 2017; April; 3(1): 7 – 1
Carolyn S P Lam,et al. Regional and ethnic differences among patients with heart failure in Asia: The Asian sudden cardiac death in heart failure registry. European Heart Journal 2016; 37,3141-3153
Carolyn S P Lam. A Prospective Observational Study (ASIANHF),ASIAN HF Registry,Clinical Trials,July 2021.
Gheorghiade M,et al. Pathophysiologic targets in the early phase of acute heart failure syndromes. Am J Cardiol. 2005;96(6A):11G-17G.
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