The FDA has granted approval to Bayer and Merck & Co's heart failure drug, Verquvo (vericiguat), marking a significant advancement in the treatment of symptomatic chronic heart failure in adults with an ejection fraction less than 45%. This approval is aimed at reducing the risk of cardiovascular death and heart failure hospitalization, offering a new therapeutic option for patients who have been hospitalized for heart failure or require outpatient IV diuretics.
Verquvo's approval is based on the outcomes of the pivotal phase 3 VICTORIA trial, which demonstrated a 4.2% reduction in the annualized absolute risk of cardiovascular death or heart failure hospitalization compared to placebo. This means that 24 patients would need to be treated over an average of one year to prevent one death or heart failure hospitalization.
The VICTORIA trial involved 5,050 patients with heart failure and an ejection fraction less than 45%, highlighting the drug's efficacy in a significant patient population. Dr. Paul W. Armstrong, a cardiologist and Distinguished University Professor of Medicine at the University of Alberta, emphasized the high risk of rehospitalization and mortality among these patients, stating that more than half are rehospitalized within a month of discharge, and approximately one in five die within two years.
Verquvo enters a competitive market, where drugs like Novartis's Entresto (sacubitril+valsartan) and AstraZeneca's Farxiga (dapagliflozin) have already established their presence. Despite the competition, Verquvo's approval is notable for being the first drug specifically approved for patients following a hospitalization for heart failure or those needing outpatient IV diuretics, based on the results of a large-scale clinical trial.
This approval not only provides a new treatment option for patients and healthcare professionals but also underscores the ongoing advancements in the management of heart failure, a condition that continues to pose significant challenges to the medical community.
