January 19, 2021

The U.S. FDA has approved Verquvo® (vericiguat), manufactured by Merck, to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure in adults who have symptomatic chronic heart failure and ejection fraction less than 45%. Under the approved indication, Verquvo should be used in patients who have required outpatient intravenous diuretics or been hospitalized for heart failure.

An estimated 6.2 million adults in the United States suffer from heart failure. The condition occurs when the heart is unable to pump enough blood and oxygen to the rest of the body, and a patient’s prognosis is dependent in part on the severity of the condition. Nearly half of patients who have been hospitalized for heart failure do not survive beyond five years. Approximately one-fifth die within two years.

In a clinical study, Verquvo given in conjunction with current standards of care reduced the annualized absolute risk of CV death or hospitalization for heart failure by 4.2% compared to placebo and current standards of care.

The recommended starting dose is 2.5mg taken by mouth once daily with food. The dose should then be doubled approximately every two weeks, as tolerated by the patient, until a target maintenance dose 10mg once daily is reached. Verquvo tablets can be crushed and mixed with water for patients who are unable to swallow them whole. A black box warning cautions that there is a risk of embryo-fetal toxicity associated with the use of Verquvo.

Merck has launched Verquvo at a wholesale acquisition cost (WAC) of $582.90 per 30 tablets.

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