Merck seeks FDA authorization for anti-COVID-19 pill
If Merck’s antiviral pill is cleared by the Food and Drug Administration, it would be the first pill shown to treat COVID-19, as other FDA-backed treatments for it require an IV or injection.
The decision could come in a matter of weeks. The FDA will scrutinize company data on the safety and effectiveness of the drug, molnupiravir, before making a decision.
Merck and its partner Ridgeback Biotherapeutic said 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 company reported earlier this month that the pill cut hospitalizations and deaths by half among patients with early symptoms. The results were so strong that independent medical experts monitoring the trial recommended stopping it early.
An antiviral pill that people could take at home to reduce symptoms and speed recovery could ease the caseload on hospitals and help curb outbreaks in poorer countries with weak health care systems.
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