FDA critiques Merck Covid therapy “as quickly as doable”

Dr. Anthony Fauci, Senior Medical Advisor to the White House, said Friday that the Food and Drug Administration will review the data on Merck and Ridgeback Biotherapeutics’ new oral antiviral drug “as soon as possible” in hopes of emergency clearance To give.

The companies said their antiviral treatment, molnupiravir, reduced the risk of hospitalization or death in unvaccinated patients with mild or moderate Covid by about 50%. In the Phase 3 clinical trial that enrolled 775 subjects who took either molnupiravir or a placebo, eight people who received the placebo died within 29 days. None of the participants taking molnupiravir died, according to data released on Friday.

“You need to make sure that you give the FDA time to go through the data very carefully and make the kind of emergency approval decisions,” Fauci told CNBC “Closing Bell.” “So I don’t want to get ahead of you. I can’t predict when it will be, but I can tell you one thing: you will do it as soon as possible.”

Merck and Ridgeback Biotherapeutics also reported that 7.3% of molnupiravir recipients in their Phase 3 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 increased their chances of having more severe Covid symptoms.

Emergency FDA approval would make molnupiravir the first oral antiviral to fight Covid. The US has approved the purchase of 1.7 million molnupiravir courses. White House Coronavirus Response Coordinator Jeff Zients told reporters at a briefing Friday that the government has the option to buy even more doses if the drug is approved.

Merck expects 10 million courses of molnupiravir to be available by the end of 2021.

When asked if molnupiravir will eventually be reserved exclusively for the unvaccinated, Fauci said he wants to avoid speculation before the FDA makes its final decision. Fully vaccinated people can still get Covid, especially if the vaccine becomes less effective, but they retain high levels of protection from serious illness and death.

“I shouldn’t pre-empt what the FDA will allow it for,” said Fauci. “But I would assume that if you are infected you are infected. It doesn’t matter whether you are vaccinated or not.”