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.”

Spotlight

Disorders of the peripheral and central nervous system are very severe in nature. They may lead to the complete degeneration of the neurological system and permanently incapacitate an individual. These disorders are observed mainly after the age of 65. But in recent years, young adults and even small children are being diagnosed with neurological diseases. The most common form of the neurological disease is “brain diseases” that is affecting the lives of millions worldwide. According to the global estimates by the World Health Organization, 1 out of every 6 people in any country suffers from one or the other type of brain disease. This has resulted in reduced life expectancy all over the world and demands attention from global health organizations.


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Spotlight

Disorders of the peripheral and central nervous system are very severe in nature. They may lead to the complete degeneration of the neurological system and permanently incapacitate an individual. These disorders are observed mainly after the age of 65. But in recent years, young adults and even small children are being diagnosed with neurological diseases. The most common form of the neurological disease is “brain diseases” that is affecting the lives of millions worldwide. According to the global estimates by the World Health Organization, 1 out of every 6 people in any country suffers from one or the other type of brain disease. This has resulted in reduced life expectancy all over the world and demands attention from global health organizations.

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