New therapeutic option to reduce risk of cardiovascular deaths and repeated hospitalizations among adult heart failure patients approved in Singapore

18 May 2022 | Wednesday | News


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.
Image Source : Public Domain

Image Source : Public Domain

  • 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.

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 StatesJapanTaiwanAustralia 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.

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