FDA Approves Bayer/Merck's Verquvo (vericiguat) as First sGC Stimulator for Worsening Chronic Heart Failure

Today, information on the U.S. FDA website indicates that the New Drug Application (NDA) for Verquvo (vericiguat), a soluble guanylate cyclase (sGC) stimulant jointly developed by Bayer and MSD, has been approved for the treatment of patients with symptomatic chronic heart failure with an ejection fraction below 45% following a worsening heart failure event. This is the first innovative drug approved by the U.S. FDA in 2021 and the first soluble guanylate cyclase (sGC) stimulant for the treatment of patients with worsening chronic heart failure.

▲Screenshot of the Verquvo (vericiguat) drug label (Image source: FDA official website)

Heart Failure with Reduced Ejection Fraction (HFrEF), formerly known as systolic heart failure, is characterized by impaired ability of the heart to eject blood adequately during its contraction phase. HFrEF accounts for 40–50% of patients with heart failure. Each year, approximately 30% of patients with symptomatic chronic heart failure experience disease worsening, and it is estimated that one in five patients with worsening chronic HFrEF will die within two years.

Verquvo is a once-daily, orally administered, directly soluble guanylate cyclase (sGC) stimulator jointly developed by Merck Sharp & Dohme and Bayer. sGC plays a critical role in vascular and cardiac function; however, in patients with heart failure, sGC is insufficiently activated, leading to impaired myocardial and vascular function. Verquvo restores the function of the key NO-sGC-cGMP signaling pathway by activating sGC. In May 2014, Bayer and Merck Sharp & Dohme entered into a research and development agreement to co-develop and commercialize Verquvo.

▲Molecular structure of Verquvo (Image source: PubChem)

This approval was supported by the results of the Phase 3 VICTORIA clinical trial. The trial specifically targeted patients with worsening chronic heart failure who were at high risk of cardiovascular death and had recurrent hospitalizations for heart failure. Data from VICTORIA have been published in the New England Journal of Medicine. At a median follow-up of 10.8 months, results showed that the Verquvo treatment group reduced the risk of the composite endpoint of heart failure hospitalization and cardiovascular death compared with the placebo group (35.5% vs. 38.5%; HR=0.90; P=0.02).

Over the past year, dapagliflozin, developed by AstraZeneca, was approved as the first SGLT2 inhibitor for the treatment of patients with heart failure with reduced ejection fraction (HFrEF). Novartis’s Entresto has also received support from the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) and is expected to be approved in the first quarter of this year for the treatment of patients with heart failure with preserved ejection fraction (HFpEF). We look forward to the early approval of more innovative and high-quality medications to benefit patients with heart failure.

Note: This article is intended to introduce medical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a qualified healthcare provider at an accredited hospital.

References:

[1] Official websites of various companies.

[2] Gilead and Vir Biotechnology Establish Clinical Collaboration to Explore Combination Strategies for Functional Cure for Chronic Hepatitis B Virus. Retrieved January 12, 2021, from http://investors.gilead.com/news-releases/news-release-details/gilead-and-vir-biotechnology-establish-clinical-collaboration

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