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A new drug application (NDA) for vericiguat, a bird nucleotide cyclase (sGC) agonist developed jointly by Bayer and MSD, has been approved to treat patients with symptomatic chronic heart failure with a blood test score of less than 45 percent after a worsening heart failure event, according to the FDA's official website.
is the first innovative drug approved by the FDA in 2021 and the first soluble bird nucleotide cyclase (sGC) agonist to treat patients with worsening chronic heart failure.
screenshot of the drug label (photo: FDA official website) Of the reduced blood score (HFrEF) type heart failure, formerly known as constrictive heart failure, is characterized by impaired heart's ability to shoot fully during its contraction phase.
HFrEF accounts for 40-50% of heart failure patients.
year, about 30 percent of patients with symptomatic chronic heart failure experience worsening of the disease, and it is estimated that one in five patients with chronic HFrEF deterioration will die within two years.
Verquvo is a direct water-soluble bird nucleotide cyclase (sGC) anthracite developed jointly by Mercadon and Bayer once a day.
sGC is important for both blood vessel and heart function, however, sGC is not fully activated in heart failure patients, leading to abnormal cardiomyopathy and vascular function.
Verquvo restores the function of the Critical Signal Pathway (NO-sGC-cGMP) by activating the sGC.
May 2014, Bayer and Mercadon reached a research and development agreement to jointly develop and promote Verquvo.
approval of the Verquvo molecular structure (Photo: PubChem) is supported by the results of a Phase 3 clinical trial called VICTORIA.
the trial specifically targeted people with increased chronic heart failure, a high risk of cardiovascular death and hospitalization for repeated heart failure.
data from Victoria have been published in the New England Journal of Medicine.
median follow-up period of 10.8 months showed that the Verquvo treatment group reduced the risk of compound endpoint death from heart failure (35.5% vs 38.5%, HR-0.90, P-0.02) compared to the placebo group.
In the past year, Dagled, developed by AstraZeneca, has been approved as the first SGLT2 inhibitor to treat patients with reduced shot fractions, and Novartis's Entresto has received support from the FDA's Advisory Committee on Cardiovascular and Kidney Medicines (CRDAC), which is expected to be approved in the first quarter of this year to treat patients with shot fractional retention heart failure (HFpEF).
we look forward to more new drugs approved as soon as possible for the benefit of heart failure patients.