FDA Approves Verquvo (vericiguat) for Chronic Heart Failure with Reduced Ejection Fraction
Key Insights
The FDA has approved Verquvo (vericiguat), developed by Bayer and Merck & Co (search), for adults with symptomatic chronic heart failure (search) and ejection fraction less than 45%.
Verquvo aims to reduce the risk of cardiovascular death and heart failure (search) hospitalization following a heart failure event or the need for intravenous diuretics.
The approval is based on the VICTORIA trial, which demonstrated a 4.2% reduction in annualized absolute risk compared to placebo when added to other heart failure (search) therapies.
The U.S. Food and Drug Administration (FDA) has approved Verquvo (vericiguat), a drug developed by Bayer and Merck & Co (search), for the treatment of adults with symptomatic chronic heart failure (search) and reduced ejection fraction (less than 45%). This approval marks a new option for patients facing a high risk of hospitalization and cardiovascular death following a heart failure event.
Clinical Efficacy
Verquvo's approval is based on the pivotal Phase 3 VICTORIA trial, which enrolled 5,050 patients with heart failure (search) and an ejection fraction of less than 45%. The study's primary endpoint was to determine if Verquvo, in combination with other heart failure therapies, was superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization following a worsening heart failure event. The results demonstrated a statistically significant 4.2% reduction in annualized absolute risk in the treatment group compared to placebo. This translates to needing to treat 24 patients over an average of one year to prevent one death or heart failure hospitalization.
Addressing Unmet Needs in Heart Failure
Heart failure (search) remains a significant public health concern, with a substantial number of patients being rehospitalized shortly after discharge. According to Dr. Paul W. Armstrong, cardiologist and study chair of the VICTORIA trial, more than half of these patients are rehospitalized within a month of discharge due to a worsening event, and approximately one in five die within two years. Verquvo is specifically indicated for patients who have recently been hospitalized for heart failure or who require outpatient intravenous diuretics, addressing a critical unmet need in this population.
Mechanism of Action and Dosing
Vericiguat is a soluble guanylate cyclase (search) (sGC) stimulator. sGC is an enzyme in the cardiopulmonary system and the target for nitric oxide (NO). When NO binds to sGC, the enzyme catalyzes synthesis of cyclic guanosine monophosphate (cGMP), a signaling molecule that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling. Heart failure (search) is associated with impaired NO synthesis and decreased sGC activity. By directly stimulating sGC, independently of and synergistically with NO, vericiguat enhances levels of cGMP, leading to smooth muscle relaxation and vasodilation.
Competitive Landscape
Verquvo enters a competitive market where other therapies, such as Novartis' Entresto (sacubitril/valsartan) and AstraZeneca's Farxiga (dapagliflozin), are already established. Entresto was approved five years prior for patients with reduced ejection fraction, while Farxiga, initially a diabetes drug, received approval for heart failure (search) with reduced ejection fraction the previous year. Boehringer Ingelheim's Jardiance (empagliflozin) is also under review for heart failure, further intensifying the competition in the SGLT2 inhibitor class.
Implications for Clinical Practice
The approval of Verquvo provides healthcare professionals with an additional tool to manage patients with symptomatic chronic heart failure (search) and reduced ejection fraction, particularly those at high risk following a hospitalization or requiring diuretic therapy. Its efficacy in reducing cardiovascular death and heart failure hospitalization, as demonstrated in the VICTORIA trial, supports its role as a valuable addition to the current treatment paradigm.