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Merck’s Vericiguat has Granted Priority from the FDA

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The U.S. Food and Drug Administration has accepted for priority review the Merck’s heart failure drug, the Vericiguat.  

The U.S. Food and Drug Administration has granted priority review status to Merck’s vericiguat. The Vericiguat will enter the increasingly congested heart failure market if the FDA gives it the green light.

Merck announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for the Vericiguat. This new drug is an orally administered soluble guanylate cyclase (sGC) stimulator. It reduces the risk of cardiovascular death and heart failure hospitalization following a worsening heart failure event in patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). 

Merck’s Vericiguat and Heart Failure

HFrEF, formerly known as systolic heart failure, is characterized by the compromised ability of the heart to eject blood sufficiently during its contraction phase. In the U.S, 6.5 million people have heart failure, and approximately 40-50% of these patients have HFrEF. Annually, approximately 30% of the patients with symptomatic chronic heart failure will experience worsening of the disease. The disease is marked by progressive symptoms and/or a recent heart failure event. Approximately half of the patients with worsening chronic HFrEF are rehospitalized within 30 days of a worsening event. Besides, an estimated one in five patients with worsening chronic HFrEF will die within two years

Collaboration between Bayer and Merck

Since October 2014, Bayer and Merck 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. Merck partnered on Vericiguat with Bayer in a $1 billion deal. The Vericiguat program is being co-developed by Bayer and Merck.