19
May
2022
|
10:00 AM
Europe/Amsterdam

Verquvo™ (vericiguat) approved in China to treat patients with chronic heart failure and reduced ejection fraction

Summary

Studied in adults with symptomatic chronic heart failure and reduced ejection fraction who are stabilized after a recent decompensation event with IV therapy / Approved in China to reduce the risk of heart failure (HF) hospitalization or the need for intravenous (IV) diuretics in emergency care / Approximately 13.7 million people in China live with heart failure(1)

Not intended for U.S. and UK Media

Berlin, Germany, May 19, 2022 - Bayer announced today that China’s National Medical Products Administration (NMPA) has approved vericiguat under the brand name Verquvo. Verquvo (2.5 mg, 5 mg, and 10 mg), a soluble guanylate cyclase (sGC) stimulator, is indicated in China to reduce the risk of heart failure (HF) hospitalization or requiring intravenous (IV) diuretics in emergency, in adults with symptomatic chronic HF and reduced ejection fraction (less than 45%) who are stabilized after a recent decompensation event with IV therapy. It works differently to existing heart failure treatments, providing a specific approach to managing chronic heart failure after a recent decompensation event with IV therapy, also known as a worsening heart failure event.1,2,3

"The approval of Verquvo is an important milestone for heart failure patients across China, providing a new option to help break the cycle of worsening heart failure events. Such events can lead to a downward spiral for many patients, resulting in repeated hospitalization," said Dr. Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer AG’s Pharmaceuticals Division and Bayer Chief Medical Officer. "With each hospital visit, the risk of death increases along with the emotional toll carried by patients and their families. For this reason, Bayer is proud to provide clinicians with access to Verquvo, to help improve outcomes and help alleviate the burden faced by patients living with chronic heart failure in China."

Current therapies block the harmful effects of the natural neurohormonal systems that are activated by the myocardial and vascular dysfunction present in heart failure. Verquvo works through a different mode of action.2,4 It specifically restores the deficient NO-sGC-cGMP pathway, which plays a critical role in the progression of heart failure and aggravating its symptoms.4 Verquvo was studied and approved on top of standard-of-care. 

Verquvo has been approved in the U.S, the EU, Japan, and many other countries worldwide. Multiple other submissions for marketing authorizations are ongoing worldwide.

Verquvo is being jointly developed with MSD (a tradename of Merck & Co., Inc., Kenilworth, NJ, USA).

About Verquvo™ (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.5 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.5 Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction.5 By directly stimulating sGC, independently of and synergistically with NO, vericiguat augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation.4 In the EU Verquvo is indicated for symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous (IV) therapy.

About the Worldwide Collaboration between Bayer and MSD
Since October 2014, Bayer and MSD 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.

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 the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating 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.

1. Hao, G., Wang, X., Chen, Z., et al. Prevalence of heart failure and left ventricular dysfunction in China: the China Hypertension Survey, 2012-2015. European Journal of Heart Failure. 2018;21: 1329-1337. 
2. Armstrong P, et al. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. The New England Journal of Medicine. 2020;14;382(20):1883-1893.
3. Butler J, et al. Clinical Course of Patients With Worsening Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2019;773(8):935-944. 
4. Pieske B, Butler J, Filippatos G, et al. Rationale and design of the SOluble guanylate Cyclase stimulatoR in heArT failurE Studies (SOCRATES). European Journal of Heart Failure. 2014 Sep;16(9):1026-38.
5. Armstrong P, et al. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of the Oral Soluble Guanylate Cyclase Stimulator: The VICTORIA Trial. JACC Heart Fail. 2018 Feb;6(2):96-104.

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Forward-Looking Statements 
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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