WASHINGTON— Drugmaker Merck has asked U.S. regulators to authorize its promising antiviral pill against COVID-19, setting the stage for a decision within weeks.
If cleared by the Food and Drug Administration, it would be the first pill shown to treat COVID-19, adding a new, easy-to-use weapon to the world's arsenal against the pandemic.
The FDA will scrutinize company data on the drug's safety and effectiveness before rendering a decision.
All COVID-19 drugs currently authorized by the FDA to fight COVID-19 require an IV or injection.
The drug, Molnupiravir, is a form of a potent ribonucleoside analog that inhibits the replication of the COVID-19 virus.
Earlier this month, Merck said trials showed the drug cut down on hospitalizations and deaths in adult patients with laboratory-confirmed mild to moderate COVID-19 who had at least one risk factor associated with poor disease outcomes.
After releasing clinical trial results, White House medical adviser Dr. Anthony Fauci said the data on the drug was promising.
"There was a 50% diminution of importance, is that in the placebo group there were eight deaths and in the treatment group, there were no deaths. That's also very important and very good news," Fauci said.
The federal government has already purchased 1.7 million doses of Merck's drug with the option to purchase more.
"If approved, I think the right way to think about this is, this is a potential additional tool in our toolbox to protect people from the worst outcomes of COVID," White House COVID-19 response team coordinator Jeff Zients said last week. "But I think it's really important to remember that vaccination remains far and away our best tool against COVID-19. It can prevent you from getting COVID in the first place, and we want to prevent infections, not just wait to treat them once they happen.