BAY-1021189; MK-1242; Verquvo

Vericiguat 

Cardiovascular – heart failure

This key emerging therapy is the first in the market to specifically address high-risk cases of chronic heart failure with reduced ejection fraction (HFrEF), who were often excluded from clinical trials of other HFrEF treatments.

About vericiguat

  1. Developed by Bayer AG and Merck & Co
  2. Soluble guanylate cyclase stimulator
  3. In the U.S., indicated for treatment of adults with chronic HFrEF (approved Jan 2021) following hospitalization for HF or receiving outpatient intravenous diuretics
  4. Undergoing MAA/NDA review by the EMA, PMDA and Chinese National Medical Products Administration (NMPA)
$1.21B
expected sales in 2025

About the HFrEF market

  1. Crowded, competitive market that has been highly genericized for decades and consists of multiple effective treatment options
  2. Recent approvals of major new drugs for HFrEF include Entresto (sacubitril/valsartan) in 2015 and Farxiga (dapagliflozin) in 2020
  3. Differentiation necessary for new entrants to be successful
30%
of HFrEF patients are rehospitalized within three months

Unmet patient needs

HF remains associated with high mortality, morbidity and hospitalization rates.

Patients with worsening HFrEF are at the highest risk of re-hospitalization and mortality, and treatments evaluated specifically for this subpopulation have been lacking.

Why is it a drug to watch?

The Phase III VICTORIA trial demonstrated a clear reduction in hospitalization rates and a trend toward reduction in cardiovascular (CV) mortality in patients with severe, deteriorating HFrEF, leading to its approval to treat HFrEF in the U.S.

For these patients, treatments that reduce hospitalizations and CV deaths remains an unmet need. Because vericiguat’s mechanism of action is distinct from current HF therapies, it can be prescribed as add-on therapy with little risk of severe side effects.

Drug switching or new drug initiation for chronic HF patients is most common post-hospitalization, which is expected to accelerate vericiguat’s uptake compared with drugs that should be initiated in stable patients, especially given its ease of use, once-daily oral dosing and simple titration.

25%
expected increase in prevalence of heart failure in the U.S. by 2030

What you need to know

Vericiguat’s novel mechanism of action should result in its acceptance as an add-on therapy to existing treatments and will be less exposed to direct competition from typical low-cost HF therapies.

It will likely find its niche among high-risk HFrEF patients, become a welcome addition to the treatment armamentarium and expand their treatment options.

“The target population for vericiguat is a pretty high-risk group of patients. I don’t think we have the data to suggest that we should use it widely in all heart failure patients, but I think this drug holds promise for people who are failing the standard of care and are coming to the hospital with worsening heart failure.”

Cardiologist,
United States

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