Drugmaker Merck asks US regulators Monday to authorize its pill against COVID-19 in what would add an entirely new and easy-to-use weapon to the world’s arsenal against the pandemic.
If cleared by the Food and Drug Administration — a decision that could come in a matter of weeks — it would be the first pill shown to treat COVID-19. All other FDA-backed treatments against the disease require an IV or injection.
An antiviral pill that people could take at home to reduce their symptoms and speed recovery could prove game-changing, easing the crushing caseload on US hospitals and helping to curb outbreaks in poorer countries with weak health care systems. It would also bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations.
The FDA will scrutinize company data on the safety and effectiveness of the drug, molnupiravir, before rendering a decision.