- Merck & Co. and Bayer on Tuesday won Food and Drug Administration approval for the heart failure drug Verquvo, one of the few medicines Merck has recently brought through late-stage development.
- The FDA cleared Verquvo to reduce the risk of cardiovascular death or hospitalization in a subset of chronic patients whose hearts can pump less than 45% of the blood in the left ventricle. Patients who have already been hospitalized or needed outpatient intravenous diuretics would be candidates for treatment.
- A Merck spokesperson said the company plans to announce the price for the drug in coming weeks, saying it will be in line with existing treatments and reflect "the value it offers to patients." Merck developed the treatment together with Bayer, which has commercial rights outside of the U.S.
While Verquvo gives Merck a new drug to sell, it's unlikely to be the next blockbuster product that investors are seeking. Steve Scala, an analyst for Cowen, previously projected sales of $500 million for the drug in 2025.
By contrast, Merck currently gets more than a quarter of its revenue from one medicine, the cancer treatment Keytruda. In the first nine months of 2020, Keytruda brought in $10.4 billion of Merck's $35.5 billion in product revenue.
The label for Verquvo is supported by data from major trial called Victoria that compared Verquvo against a placebo in combination with existing heart treatments. In the study, patients on Verquvo saw a reduction in the combined endpoint of cardiovascular death and hospitalization.
But the improvement was mainly driven by fewer hospitalizations, with an analysis showing no significant effect on lessening deaths. The overall benefit, detailed in March 2020, was also more modest than some analysts and investors had expected.
Cowen's Scala predicted Verquvo will be used as one of the last options for very severe patients. Doctors polled by SVB Leerink around the time of the Victoria study release said they would likely use the drug for patients who can't take existing treatments or aren't getting enough benefit from them.
Some 6.2 million adults in the U.S. suffer from heart failure, and about half have reduced ejection fraction, the measure of blood pumping from the left ventricle, Merck said. Many of those patients face the prospect of rehospitalization within just 30 days.
Merck said Verquvo is the first drug approved to treat heart disease that works by stimulating an enzyme called soluble guanylate cyclase to improve heart function.
The drug will carry a boxed warning telling doctors not to prescribe it for pregnant women. Animal studies suggested it might cause harm to a fetus.