Merck & Co. has officially applied for U.S. emergency use authorization for its oral pill to treat mild-to-moderate COVID-19.
If approved, the Merck pill will become the first oral antiviral medication against the respiratory disease. All other approved treatments against COVID-19 require an injection.
An antiviral pill that people could take at home to reduce their symptoms and speed recovery could prove ground-breaking, easing the crushing caseload on U.S. hospitals and helping to curb outbreaks in poorer countries with weak healthcare systems.
The U.S. Food and Drug Administration (FDA) will scrutinize company data on the safety and effectiveness of the drug, molnupiravir, before rendering its decision on the Merck pill.
Merck has said that they specifically asked the agency to grant emergency use for adults with mild-to-moderate COVID-19 who are at risk for severe disease or hospitalization.
The pharmaceutical company reported earlier this month that the pill cut hospitalizations and deaths by half among patients with early symptoms of COVID-19. The results were so strong that independent medical experts monitoring the trial recommended stopping it early.
Side effects were similar between patients who got the drug and those in a testing group who received a placebo. But Merck has not publicly detailed the types of problems its pill has encountered, which will be a key part of the FDA’s review.
U.S. officials continue to push vaccinations as the best way to protect against COVID-19. But with some 68 million eligible Americans still unwilling to get the shots, effective drugs will be critical to controlling future waves of infection.
Assuming FDA approval, the U.S. government has agreed to buy enough of the pills to treat 1.7 million people, at a price of roughly $700 for each course of treatment.