Bayer launches vericiguat (Verquvo™) in India, the first novel treatment approved to reduce the risk of cardiovascular deaths

27-09-2022 Tue 16:34 | Technology | Press Release

In India there are between 8-10 million people with heart failure (HF), making it one of the largest HF populations in the world.
Indian heart failure patients are a decade younger than their western counterparts, the average age being 55 – 60 yrs.
Despite the substantially younger age of patients 3 out of every 5 Indian patients will die within 5 years of their diagnosis.
VERQUVO™ (vericiguat) is the first soluble guanylate cyclase stimulator, a new class of drugs, which works on a pathway not currently targeted by existing heart failure treatments and was studied in a population with a higher risk of cardiovascular death or heart failure hospitalization

Mumbai, 27 September 2022: Bayer today announced the launch of vericiguat (VerquvoTM), a soluble guanylate cyclase (sGC) stimulator, in India. Vericiguat is indicated, along with guideline-based medical therapy, in adults with symptomatic chronic heart failure with reduced ejection fraction (less than 45%), following a recent event of worsening heart failure which required hospitalization or outpatient intravenous (IV) diuretics. 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.

Chronic heart failure (HF) is a substantial economic and public health burden affecting more than 8-10 million people in India. The average age of an Indian heart failure patient is a decade younger than their western counterparts being 55 – 60 yrs. 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.

Mr. Manoj Saxena, Managing Director, Bayer Zydus Pharma, says, “Bayer is pleased to bring VerquvoTM 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[v]. 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 i,ii. Verquvo can help patients stay out of the hospital and improve the chances of survival in such patients

Chronic heart failure occurs when the heart is not able to pump blood as well as it should. Certain conditions such as the thickening of arteries (atherosclerosis), heart attack, infections, or rheumatic heart disease make the heart muscle weak or stiff, so that it cannot pump blood effectively. In patients with chronic heart failure, an event of worsening heart failure can happen at any stage. 90% of patients who suffer from the worsening event are not in the advanced stage of chronic heart failure

Bayer has received approval of vericiguat (VerquvoTM) 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.

Vericiguat is currently approved for use in 35 countries including the United States, European Union countries, the United Kingdom, Japan and Singapore. 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 in around the world.

Vericiguat is approved for use by the U.S. Food and Drug Administration (FDA) in January 2021, and by the European Commission in July 2021.

About Vericiguat

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 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.com.