FDA Grants Priority Review to Bayer/MSD's New Drug Application for Vericiguat in Worsening Chronic Heart Failure

On July 16, Bayer and MSD jointly announced that the U.S. FDA had accepted the New Drug Application (NDA) for vericiguat and granted it Priority Review designation for the treatment of patients with symptomatic chronic heart failure with an ejection fraction less than 45% following a worsening heart failure event. The FDA is expected to respond by January 20, 2021. If approved, vericiguat is poised to become the first soluble guanylate cyclase (sGC) stimulator for the treatment of patients with worsening chronic heart failure.

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. In the United States, 6.5 million people have heart failure, and approximately 40–50% of these patients have HFrEF. Each year, about 30% of patients with symptomatic chronic heart failure experience disease worsening. Among patients with worsening chronic HFrEF, approximately half are rehospitalized within 30 days following the worsening event, and an estimated one in five will die within two years.

Vericiguat is an oral, once-daily, 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. Vericiguat actively restores the function of the nitric oxide–sGC–cGMP pathway, a key signaling cascade not adequately addressed by current therapies. In May 2014, Bayer and Merck Sharp & Dohme entered into a research and development agreement to co-develop and commercialize vericiguat.

▲Molecular structure of vericiguat (Image source: PubChem)

The New Drug Application submitted to the FDA is based on the results of the Phase 3 VICTORIA trial, the first contemporary outcomes study specifically targeting patients with worsening chronic heart failure who are at high risk of cardiovascular death and have recurrent heart failure hospitalizations. Data from the VICTORIA trial were simultaneously presented at the 69th Annual Scientific Session of the American College of Cardiology and the World Congress of Cardiology (ACC.20/WCC) and published in The New England Journal of Medicine. The study results demonstrated that, compared with placebo, vericiguat reduced the risk of the composite endpoint of heart failure hospitalization or cardiovascular death. With a median follow-up of 10.8 months, vericiguat reduced the risk of heart failure hospitalization and cardiovascular death compared with placebo (35.5% vs. 38.5%; hazard ratio [HR], 0.90).

Dr. Joerg Moeller, Head of Bayer’s Research and Development Division, stated, “Heart failure is the leading cause of hospitalization among patients aged 65 and older, affecting more than 60 million people worldwide. Despite receiving existing treatments, many patients with heart failure still experience disease progression, leading to recurrent hospitalizations. The submission of the marketing application for vericiguat holds promise for keeping heart failure patients out of the hospital and maintaining their health for longer periods.”

Dr. Roy Baynes, Chief Medical Officer, Senior Vice President, and Head of Global Clinical Development at MSD Laboratories, stated, “We look forward to collaborating with the FDA to expedite the review of the new drug application for vericiguat.”

References:

[1] FDA Grants Priority Review to Merck’s New Drug Application for Vericiguat. Retrieved 2020-07-16, from https://www.businesswire.com/news/home/20200716005203/en/FDA-Grants-Priority-Review-Mer

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