- Merck & Co. and Bayer's experimental heart failure drug vericiguat, when added to normal treatment, kept chronic heart failure patients out of the hospital better than the older drugs alone, according to results from a study known as VICTORIA.
- The drug didn't prevent death from heart disease, however, prompting physicians and analysts to forecast its use being limited to last-line therapy, potentially a more niche market.
- Merck needs to build out its drug pipeline to prepare for the eventual patent expiration in 2028 of cancer drug and top-seller Keytruda. Vericiguat is one of only four experimental Merck drugs in Phase 3 development.
After releasing data at the virtual meeting of the American College of Cardiology on Saturday, Merck said it will be discussing the VICTORIA study with the Food and Drug Administration, but did not say when it plans to file for approval. The big pharma's executive team could reveal its plans at its first quarter earnings call on April 28.
In spite of treatment advances, chronic heart failure continues to be a difficult diagnosis, with a majority of patients dying within five years. Patients in the VICTORIA trial were a particularly sick group, with hearts so weak that they can only pump out 45% or less of the blood in the left ventricle.
The study enrolled patients who had recently been hospitalized or received acute treatment for an episode of "decompensation," during which shortness of breath, lower limb swelling or fatigue emerge in spite of ongoing treatment.
The study succeeded by showing vericiguat delayed another hospitalization for worsening heart failure or death from cardiovascular causes. Adding the therapy reduced the risk of those two events by 10% when compared to older drugs. However, that benefit was driven by fewer hospitalizations, as the risk of cardiovascular deaths was not significantly lessened.
Physicians and payers may also look closely at a measure known as "number need to treat" to prevent one cardiovascular death or hospitalization. Trial investigators estimated that figure was 24.
"When a physician tries to figure out [whether she should] put a patient on a drug, it's not the relative risk reduction they look at, but how many patients do I have to treat," Joerg Koglin, Merck's global cardiovascular clinical development chief, said in an interview with BioPharma Dive. "Numbers below 40 or 30 are considered very convincing numbers by physicians and even payers."
However, the primary result was more modest than the expectations of investors polled by investment bank Cowen & Co., who anticipated there would be a 20% risk reduction, analyst Steve Scala wrote in a March 30 note to investors.
"Vericiguat appears destined for use as last line therapy for very severe patients, likely a small population," Scala wrote in forecasting sales of $500 million in 2025.
Physicians polled by SVB Leerink said they would be most likely to prescribe vericiguat in patients who can't tolerate existing standard-of-care drugs or still have heart failure symptoms while taking those drugs. Analyst Daina Graybosch of SVB Leerink forecasted peak sales of $300 million.