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Berlin, Germany, May 21, 2021 – The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended vericiguat, a soluble guanylate cyclase (sGC) stimulator, for marketing authorization in the European Union. Once approved, the use of vericiguat (2.5 mg, 5 mg, and 10 mg) will be authorized for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring intravenous (IV) therapy.
“Even when taking guideline-based therapy, many heart failure patients still experience progressive worsening of symptoms – meaning hospitalization or initiation of intravenous diuretics is needed. This is one of the biggest challenges still to be addressed in the management of chronic heart failure, as sadly, one in five do not survive for longer than two years after a worsening heart failure event,” said Dr. Burkert Pieske, professor of internal medicine and cardiology at Charité and principal investigator of the Phase III VICTORIA trial. “Once approved, vericiguat will be the first treatment option to have been studied specifically in patients after a recent decompensation in order to help break the cycle of worsening events, reduce the risk of re-hospitalization and hopefully make a meaningful difference to the lives of both patients and their families.”
“Heart failure is the leading cause of hospitalization in Europe. With half of patients being readmitted within 30 days of hospitalization or initiation of intravenous diuretics, this represents a significant burden for both patients and health systems more broadly,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer AG's Pharmaceuticals Division and Head of Research and Development. “We’re pleased to have received a positive CHMP opinion for vericiguat, as it brings us one step closer to providing a new treatment option with the potential to alleviate this burden, helping improve outcomes and the management of chronic heart failure for high-risk patients.”
The positive CHMP opinion is based on the results of the pivotal Phase III VICTORIA trial, published in The New England Journal of Medicine (NEJM) in March 2020. The data showed that vericiguat significantly reduced the combined risk of cardiovascular death or heart failure hospitalizations compared to background therapy alone, following a worsening heart failure event.(1)
Vericiguat has been approved by the U.S. Food and Drug Administration (FDA) under the brand name Verquvo™ and the final decision from the European Commission is expected in the coming months. Vericiguat has been submitted for marketing authorization in Japan and China as well as multiple other countries worldwide.
Vericiguat is being jointly developed with MSD (a tradename of Merck & Co., Inc., Kenilworth, NJ, USA).
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 the Worldwide Collaboration between Bayer and MSD
Since October 2014, Bayer and MSD (known as Merck & Co., Inc. in the U.S. and Canada) have pursued a worldwide collaboration in the field of sGC modulators. The collaboration brings together two leading companies that have stated their intent to fully evaluate this therapeutic class in areas of unmet medical need. The vericiguat program is being co-developed by Bayer and MSD. MSD has the commercial rights to vericiguat in the U.S. and Bayer has the exclusive commercial rights in the rest of world. The companies share equally the costs of the development of vericiguat.
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.
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.
(1) Armstrong P, Pieske B, Anstrom KJ, et al. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. New England Journal of Medicine, 28 March 2020.
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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.
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