The Mercadon/Bayer heart failure drug Vericiguat has been approved by the FDA

The Mercadon and Bayer heart failure drug Vericiguat has been approved by the U.S. Food and Drug Administration (FDA) to treat patients with symptomatic chronic heart failure with a blood test score of less than 45 percent after a worsening heart failure event.
approved, Vericiguat will be sold under the Verquvo brand.
Vericiguat 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.
Vericiguat is a long-lived, soluble bird nucleotide cyclase (sGC) stimulant that is orally given, while the lack of sGC-derived cGMP can lead to impaired cardiomyopathy and endotent dependent vascular contraction.
Vericiguat, the first sGC direct stimulator for heart failure treatment, improves cardiomyopathy and vascular function by restoring the NO-sGC-cGMP signaling pathrain.
Vericvo, developed by Mercado and Bayer, is a multi-center, parallel group, randomized, placebo-controlled, event-driven Phase III clinical study designed to assess whether Vericiguat can prolong the duration of cardiovascular death and first hospitalization of HFrEF patients in standard treatment contexts, as phase III VICTORIA results are reviewed by the FDA as a priority review by the FDA.
trial included 5,050 chronically ill patients from 42 countries and regions around the world, who were randomly divided into two groups on a 1:1 scale and treated with Vericiguat (2,526) and placebo (2,524) respectively in the context of combined heart failure standard treatment.
trial reached its primary endpoint, with studies showing that the addition of Vericiguat to the patient group significantly reduced the risk of complex endpoints of recent heart failure events compared to the standard treatment group.
patients with a medium follow-up period of 10.8 months showed that the Vericiguat treatment group reduced the risk of compound endpoint death from heart failure hospitalization and cardiovascular causes (35.5% vs. 38.5%, HR =0.90, P=0.02) compared to the placebo group.
3 months of treatment, the differences shown in favour of Vergioguat persisted throughout the study.
secondary endpoint analysis showed a significant decrease in hospitalizations for heart failure in the Vericiguat group (27.4% vs. 29.6%) and a significant decrease in compound endpoints (37.9% vs. 40.9%) in the Vericiguat group compared to the placebo group.
the results of the trial are now published in the New England Journal of Medicine.
safety analysis of the Vitoria trial showed that Vericiguat had good tolerance and that Vericiguat showed adverse events similar to placebos.
, Vericiguat had slightly higher rates of adverse drug reactions than placebos, including low blood pressure (16% vs. 15%) and anemia (10% vs. 7%).
note that the drug is labeled with a boxed warning that the drug should not be used in pregnant women because Verquvo can cause fetal harm.
sources: 1, Merck and Bayer Win FDA Approval for Heart Failure Drug 2, Merck Announces U.S. FDA Approval for VERQUVO® 3, FDA OKs Vericiguat for Unique HF Population