Merck's (MRK) Heart Failure Drug Vericiguat Gets FDA Nod

Merck MRK announced that the FDA has granted approval to its and its Germany-based partner Bayer’s BAYRY vericiguat, a soluble guanylate cyclase (sGC) stimulator, to treat patients with worsening chronic heart failure with reduced ejection fraction (HFrEF).

Vericiguat will be marketed by the brand name of Verquvo to reduce the risk of cardiovascular death and heart failure hospitalization, following hospitalization for heart failure or need for outpatient intravenous (IV) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%.

However, the approval comes with a boxed warning that indicates that the drug should not be given to pregnant ladies because it may cause fetal harm.

In the past year, Merck’s shares have declined 8.3% against an increase of 6.1% for the industry.

 

 

The FDA approval for the candidate was based on data from the phase III VICTORIA study. The VICTORIA study evaluated vericiguat versus placebo when given in combination with available heart failure therapies in patients with symptomatic chronic heart failure and ejection fraction less than 45% following a worsening heart failure event.

Data from the study showed that vericiguat was superior to placebo in reducing the risk of composite endpoint of heart failure hospitalization or cardiovascular death in such patients. The data showed that there was a 4.2% reduction in annualized absolute risk with Verquvo compared with placebo. Verquvo tablets (2.5 mg, 5 mg, and 10 mg) have been jointly developed by Bayer and Merck.

Novartis’ NVS Entresto is approved to treat HFrEF. However, Verquvo is the first treatment for chronic heart failure approved specifically for patients following hospitalization for heart failure or need for outpatient IV diuretics.

Cytokinetics’ pipeline candidate, omecamtiv mecarbil is in late-stage development for HFrEF. Cytokinetics was earlier developing omecamtiv mecarbil with Amgen AMGN. However, in November last year, Amgen transitioned development and commercialization rights to omecamtiv mecarbil to Cytokinetics.

Merck currently carries a Zacks Rank #2 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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