SINGAPORE, May 17, 2022 /PRNewswire/ -- 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, 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.[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, a new class of drugs, is effective in reducing hospitalisations in a high-risk population of patients with worsening heart failure and reduced ejection fraction," said Professor 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, 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.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to www.bayer.com.
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This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
