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Merck Gets Priority Review in NDA for Vericiguat
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The company said FDA has set a date of January 20, 2021, for action under the Prescription Drug User Fee Act.
FDA this week accepted Merck’s New Drug Application for priority review for vericiguat, an oral soluble guanylate cyclase (sCG) stimulator, to cut the risk of cardiovascular death and heart failure hospitalization after an event in certain patients with chronic failure, the company announced.
The company said FDA has set a date of January 20, 2021, for action under the Prescription Drug User Fee Act. Merck is developing the drug with Bayer AG.
This week’s announcement follow’s presentation of results from the phase 3 VICTORIA trial in late March during the American College of Cardiology Scientific Sessions, one of the first major meetings to be held in a virtual format due to the coronavirus disease 2019 pandemic. Results were also published in the New England Journal of Medicine.
“This submission builds on Merck’s commitment to patients with cardiovascular disease and long legacy of advancing cardiovascular research to meet unmet medical needs,” Roy Baynes, MD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said in a statement. “We look forward to working with the FDA as they review this New Drug Application for vericiguat.”
Results from VICTORIA showed that for heart failure patients with reduced ejection fraction who show signs of decline while taking standard medication, vericiguat may stem the tide. Results showed those taking vericiguat had fewer events, less hospitalization, and less risk of death from any cause than those taking placebo.
However, a subgroup analysis showed more substantial benefit among those patients before they were among the “sickest of the sick,” according to an interview with Javed Butler, MD, MPH, MBA, chairman of the Department of the University of Mississippi.
