By Kathleen Doheny
Soon after Merck announced on October 1 that it would ask federal regulators for emergency use authorization (EUA) for its auspicious new COVID-19 pill, the accolades began.
Former US Food and Drug Administration (FDA) chief Scott Gottlieb, MD, told CNBC the drug was “a profound game-changer.” Top infectious disease expert Anthony Fauci, MD, called the early data “impressive.” The World Health Organization termed it “certainly good news,” while saying it awaits more data.
Merck, partnering with Ridgeback Biotherapeutics on the investigational oral antiviral medicine molnupiravir, plans also to submit applications to regulatory agencies worldwide, hoping to deliver the first oral antiviral medication for COVID-19.
Interim clinical trial results show that the drug may slash the risk for hospitalization or death by 50% in those with mild-to-moderate COVID.
When the results were found to be so favorable, the study was halted at the recommendation of an independent data-monitoring committee and in consultation with the FDA.
That initial enthusiasm is now tempered with some perspective on the pros and cons. “This anticipated drug has gotten a little more hype than it deserves,” says William Schaffner, MD, professor of preventive medicine and infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tennessee. He and others suggest a reality check.
“It’s not exactly a home run, like penicillin for strep throat,” agrees Carl Fichtenbaum, MD, professor of infectious diseases at the University of Cincinnati College of Medicine in Ohio, who is investigating a similar pill for a rival company, Atea, partnering with Roche.
“But it is encouraging,” he said. “It will probably be an incremental improvement on what we have.” The fact that it can be taken at home is a plus: “Anything we can do to keep people from getting sicker is a good thing.”
“The data show in this higher risk group [those who were studied had at least one risk factor for severe COVID, such as age or a medical condition], it reduces the risk of advancing to severe disease by 50%,” Schaffner said. While that’s a clear benefit for half, it of course leaves the other half without benefit, he said.
Others critiqued the predicted cost of the drug. The US government has already agreed to pay about $700 per patient, according to a new report from Harvard and King’s College Hospital. That same analysis also concluded that the actual cost of production for the 5-day course is only $17.74.