Merck applies for approval of first COVID-19 antiviral pill
Today, pharmaceutical giant Merck submitted an emergency use authorization (EUA) application to the Food and Drug Administration (FDA)for molnupiravir, its oral antiviral medication, for the treatment of mild to moderate COVID-19 in adults at risk for severe disease.
This category includes patients over 60 years and those diagnosed as having obesity, diabetes, or heart disease.
The drug, named after Thor’s hammer in Norse mythology, would be the first pill authorized by the FDA to treat COVID-19. Other antivirals used to fight COVID-19 have to be injected or administered intravenously. Merck has previously said that, if approved, the company is ready to supply the US government with1.7 million doses of the antiviral.
The submission is based on positive results from a phase 3 trial of the drug, which showed that molnupiravir reduced the risk of hospitalization or death by approximately 50%.
“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” said Robert M. Davis, Merck chief executive officer and president, in a companypress release.