The White House’s chief medical adviser, Dr. Anthony Anthony Fawcett, said Friday that the Food and Drug Administration will review data from Merck and Ridgeback Biotherapeutics’ new Covid Oral Antiviral in hopes of issuing emergency use approvals “as soon as possible.”
The companies said that their antiviral treatment has reduced the risk of hospitalization or death of patients with molnupiravir, mild or moderate covid, by about 50%. In a three-stage clinical trial, which enrolled 775 trial participants who took Molnupirvir or a placebo, 8 people who received a placebo died within 29 days. According to information released on Friday, none of the participants who received Molnupirvi died.
“You have to make sure that you give the FDA time to look at the data very carefully and make the kind of decision that allows for emergency use,” Fawcett told CNBC’s “Closing Bell.” “So I don’t want to go in front of them. I can’t predict when, but I can tell you one thing: they will do it as soon as possible.”
Mark and Rizbak Biotherapeutics further stated that in their third phase study, 7.3% of Molnupirvi recipients were hospitalized within 29 days, while 14.1% of placebo recipients were hospitalized or died. All participants had at least one health condition that increased their chances of developing more severe covid symptoms.
Emergency use approval from the FDA will make Molnupirvir the first oral antiviral to fight covid. The United States has agreed to buy 1.7 million courses in Molnupirvir. Jeff Giants, the White House coronavirus response coordinator, told reporters at a briefing on Friday that the government has the option to buy more drugs if the drug is approved.
Merak plans to have 10 million courses available in Molnupirvir by the end of 2021.
Asked if Molnupirvir would eventually be reserved exclusively for vaccinated people, Fausi said he wanted to avoid speculation before the FDA made its final decision. Fully vaccinated people can still be infected with covid, especially when the effectiveness of the vaccine is reduced, but they maintain a high level of protection against serious illness and death.
“I shouldn’t go further than what the FDA will approve,” Fawcett said. “But I’ll assume that if you’re infected, you’re infected. It doesn’t really matter if you’ve been vaccinated.”