Merck and Bayer Enter the Congested Market of Heart Failure with Verquvo

January 20th, 2021 – It has been a year since Merck announced a surprise Phase 3 success for Verquvo, a heart drug that it bought from Bayer for $1 billion. Today, the FDA has approved the drug to treat patients with chronic heart failure with reduced ejection fraction (HFrEF).

However, the drug’s usage will be limited to a niche population of HFrEF patients who have been recently hospitalized or received diuretics as outpatients for chronic heart failure and reduced ejection fraction.

Verquvo: A welcome new option to currently available therapies

Verquvo is a stimulator of sGC, an enzyme in the nitric oxide (NO) signaling pathway, a key pathway in cardiovascular function. By spurring the sGC enzyme directly, verquvo relaxes the smooth muscles and regulates heart contractility.

The FDA approval is based on the pivotal VICTORIA trial that determined the drug’s effect on a composite measure of the risk of cardiovascular death or heart failure hospitalization in adults with HFrEF.

The trial determined that with the drug treatment, there was a 4.2% reduction in annualized absolute risk as compared to the placebo. This parameter gives a measure of how many patients a doctor needs to treat with a new therapy to prevent one heart failure hospitalization or CV death.

According to a statement, “24 patients would need to be treated with Verquvo over an average of one year to prevent one primary endpoint event.”

According to Dr. Paul W. Armstrong, a cardiologist and Distinguished University Professor of Medicine at the Canadian VIGOUR Centre, University of Alberta, and study chair of the VICTORIA trial, “Patients with symptomatic chronic heart failure and reduced ejection fraction have a high risk for hospitalization after experiencing symptoms of heart failure requiring outpatient IV diuretic treatment or hospitalization. By some estimates, 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.”

Therefore, a drug that keeps the patients away from hospitals is most pleasing for a physician, and a patient and Verquvo is effective at doing that. While Verquvo is better at reducing rates of re-hospitalization, it is not clear how it fares at reducing cardiovascular deaths.

Stiff competition

Verquvo is entering a market that is expected to increase from $3.7 billion in 2018 to $22.1 billion in 2028. However, this market is already congested with contenders that came prior in the field, leaving little space for Merck and Bayer’s drug to grab.

Novartis’ Entresto is approved worldwide to treat HFrEF and is expected to generate about $3 billion in annual revenue. Last year, AstraZeneca’s SGLT2 inhibitor, Farxiga, got a green light from the FDA for a similar indication and is expected to pull a big chunk of the market share.

In addition to facing stiff competition, Bayer believes that the drug’s contribution to its revenue will be modest, as it is made for a selected population of patients. Last year, Bayer put the peak sales potential of Verquvo at $570 million, which is well below the levels already achieved by Novartis’ Entresto.

Related Article: FDA Greenlights Pfizer’s Xalkori for a Rare Form of Non-Hodgkin Lymphoma

References

1. https://www.merck.com/news/merck-announces-u-s-fda-approval-of-verquvo-vericiguat/

Author

Ruchi Jhonsa