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FDA Accepts Merck's NDA For Vericiguat For Priority Review - Quick Facts

Merck & Co., Inc. (MRK), known as MSD outside the United States and Canada, announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for vericiguat.

The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of January 20, 2021. Vericiguat is being jointly developed with Bayer AG.

Vericiguat is an orally administered soluble guanylate cyclase (sGC) stimulator, to reduce 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), in combination with other heart failure therapies.

The NDA is based on results from the Phase 3 VICTORIA trial, which is the first contemporary outcomes study focused exclusively on a population with worsening chronic heart failure who are at high risk for cardiovascular mortality and repeated heart failure hospitalizations.

VICTORIA is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, Phase 3 study of vericiguat versus placebo when given in combination with available heart failure therapies in patients with worsening chronic heart failure.

The study enrolled a total of 5,050 patients who were randomly selected to receive either vericiguat once daily (titrated up to 10 mg) or placebo when given in combination with available heart failure therapies.

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