Bayer on Tuesday announced the launch of vericiguat (Verquvo), a soluble guanylate cyclase (sGC) stimulator, in India. According to the company, vericiguat is indicated, along with guideline-based medical therapy, in adults with symptomatic chronic heart failure with reduced ejection fraction (less than 45 percent), following a recent event of worsening heart failure which required hospitalization or outpatient intravenous (IV) diuretics.
The pharma company claims that vericiguat works on a pathway not currently targeted by existing heart failure treatments and can reduce the risk of cardiovascular death and heart failure hospitalization in such patients.
In India, Chronic heart failure (HF) is a substantial economic and public health burden affecting more than 8-10 million people. According to reports, the average age of an Indian heart failure patient is a decade younger than their western counterparts being 55 – 60 years.
Studies point out that despite the substantially younger age of patients with HF in India, the 5-year mortality rate is 60%. HF remains the commonest cardiac cause of hospitalization in India with worsening heart failure events being one of the most important causes of death in heart failure patients.
“Bayer is pleased to bring Verquvo to India in the week of World Heart Day, as a new treatment option for worsening heart failure patients to reduce frequent hospitalizations and the risk of death. Despite therapy, chronic heart failure patients can experience disease progression that disrupts their lives and leads to worsening heart failure events, where hospitalization or initiation of intravenous diuretics are needed. After an event of worsening heart failure, more than 50% of patients may require re-hospitalization within 30 days. The in-hospital mortality rate in India is also high and registry data suggest that it ranges between 10–30.8% as compared with 4–7% in Western countries. Verquvo can help patients stay out of the hospital and improve the chances of survival in such patients,” Manoj Saxena, Managing Director, Bayer Zydus Pharma, said in a statement.
When the heart is unable to pump blood normally, it leads to chronic heart failure. According to experts, certain conditions such as the thickening of arteries (atherosclerosis), heart attack, infections, or rheumatic heart disease make the heart muscle weak or stiff, so it cannot pump blood effectively. In patients with chronic heart failure, an event of worsening heart failure can happen at any stage. 90 percent of patients who suffer from the worsening event are not in the advanced stage of chronic heart failure, studies reveal.
“Bayer has received approval of vericiguat (Verquvo) in India based on the results of the pivotal Phase III VICTORIA trial, published in The New England Journal of Medicine (NEJM) in March 2020vii. The Phase III VICTORIA data showed that vericiguat significantly reduced the combined risk of cardiovascular death and heart failure hospitalizations compared to background therapy alone, following a worsening heart failure event,” the company stated on Tuesday.
Currently, vericiguat is approved for use in 35 countries including the United States, European Union countries, the United Kingdom, Japan, and Singapore. Meanwhile, vericiguat is the only treatment that has been recommended following a worsening heart failure event, on top of foundational heart failure therapies in major international guidelines including the European Society of Cardiology (ESC) Guidelines, American Heart Association (AHA), American College of Cardiology (ACC), the Heart Failure Society of America (HFSA) and also the Canadian Heart Failure Society/Canadian Cardiovascular Society (CCS/CHFS) Heart Failure Guidelines.
Verquvo will be made available to address the needs of HF patients in India at an India-specific price, almost at the same time as HF patients around the world. In July last year, vericiguat is approved for use by the U.S. Food and Drug Administration (FDA) in January 2021, and by the European Commission.