White House chief medical advisor Dr. Anthony Fauci said Friday that the Food and Drug Administration (FDA) will review Merck and Ridgeback Biotherapeutics’ new Covid-19 oral antiviral “as quickly as they possibly can.”
The companies said that molnupiravir reduced the risk of hospitalization or death for unvaccinated patients with mild or moderate Covid symptoms by about 50%. In the phase three clinical trial, which enrolled 775 trial participants who took either molnupiravir or a placebo, eight people who received the placebo died within 29 days. None of the participants who took molnupiravir died, according to the data.
“You’ve got to make sure you give the FDA time to very carefully go over the data and make the kind of determinations for emergency use authorization,” Fauci told CNBC’s “Closing Bell.” “So I don’t want to get ahead of them. I can’t predict when it will be, but I can tell you one thing: They will do it as quickly as they possibly can.”
Merck and Ridgeback Biotherapeutics also said that 7.3% of molnupiravir recipients in their phase three study were hospitalized within 29 days, while 14.1% of placebo recipients were hospitalized or died. All participants had at least one health condition that elevated their chances for more severe Covid symptoms.
