Bayer’s new heart drug Vericiguat is approved in China

On May 19, 2022, China’s National Medical Products Administration (NMPA) approved the marketing application for Bayer’s Vericiguat (2.5 mg, 5 mg, and 10 mg) under the brand name Verquvo™.

This drug is used in adult patients with symptomatic chronic heart failure and reduced ejection fraction (ejection fraction <45%) who are stabilized after a recent decompensation event with intravenous therapy, to reduce the risk of hospitalization for heart failure or emergency intravenous diuretic therapy.

The approval of Vericiguat was based on positive results from the VICTORIA study, which demonstrated that Vericiguat can further reduce the absolute risk of cardiovascular death and hospitalization for heart failure by 4.2% (event absolute risk reduction/100 patient-years) for patients with heart failure who had a recent heart failure decompensation event and were stable on intravenous therapy with reduced ejection fraction (ejection fraction <45%).

In January 2021, Vericiguat was approved in the United States for the treatment of symptomatic chronic heart failure in patients with ejection fraction below 45% after experiencing a worsening heart failure event.

In August 2021, the new drug application for Vericiguat was accepted by the CDE and subsequently included in the priority review and approval process on the grounds of “clinically urgent drugs, innovative drugs and improved new drugs for the prevention and treatment of major infectious diseases and rare diseases”.

In April 2022, the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure, which was jointly issued by the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Failure Society of America (HFSA), updated the pharmacologic treatment of heart failure with reduced ejection fraction (HFrEF) and included Vericiguat into the drugs used for treatment of patients with high-risk HFrEF and heart failure exacerbations based on standard therapy.

Vericiguat is a sGC (soluble guanylate cyclase) stimulator with novel mechanism jointly developed by Bayer and Merck Sharp & Dohme (MSD). It can directly intervene in the cell-signaling mechanism disorder and repair NO-sGC-cGMP pathway.

Preclinical and clinical studies have shown that NO-soluble guanylate cyclase (sGC)-cyclic guanosine monophosphate (cGMP) signaling pathway is a potential target for chronic heart failure progression and heart failure therapy. Under physiological conditions, this signaling pathway is a key regulatory pathway for myocardial mechanics, cardiac function, and vascular endothelial function.

Under the pathophysiological conditions of heart failure, increased inflammation and vascular dysfunction reduce NO bioavailability and downstream cGMP synthesis. cGMP deficiency leads to dysregulation of vascular tension, vascular and cardiac sclerosis, fibrosis and hypertrophy, and coronary and renal microcirculatory dysfunction, thus further leading to progressive myocardial injury, increased inflammation and further decline in cardiac and renal function.

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