U.S. FDA allows priority review to new drug application for vericiguat treating chronic heart failure

Merck | July 17, 2020

U.S. FDA allows priority review to new drug application for vericiguat treating chronic heart failure
Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for vericiguat, 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 FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of Jan. 20, 2021. Vericiguat is being jointly developed with Bayer AG.

“This submission builds on Merck’s commitment to patients with cardiovascular disease and long legacy of advancing cardiovascular research to meet unmet medical needs,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We look forward to working with the FDA as they review this New Drug Application for vericiguat.”

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Transitional care encompasses a broad range of services and environments designed to promote the safe and timely passage of patients between levels of health care, across care settings, and among various providers. Care settings can include a range of points of care such as hospitals, long-term care facilities, rehab centers, skilled nursing facilities, and home health care. Providers can include a variety of care team members such as physicians, specialists, nurses, care/case managers, pharmacists, visiting nurses, nutritionists, interpreters, and transportation assistance.

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Spotlight

Transitional care encompasses a broad range of services and environments designed to promote the safe and timely passage of patients between levels of health care, across care settings, and among various providers. Care settings can include a range of points of care such as hospitals, long-term care facilities, rehab centers, skilled nursing facilities, and home health care. Providers can include a variety of care team members such as physicians, specialists, nurses, care/case managers, pharmacists, visiting nurses, nutritionists, interpreters, and transportation assistance.