Merck Submits COVID Antiviral Pill for EUA

October 11, 2021

This morning, the pharmaceutical company Merck submitted an application for EUA of their COVID-19 oral antiviral pill. If accepted, this will become the first pill authorized by the FDA to treat COVID-19. Other FDA authorized COVID-19 treatments must be administered intravenously or via injection.
The antiviral, called Molnupiravir, will be used to treat mild-to-moderate COVID-19 in adults who are at risk of progressing to severe COVID-19, including hospitalization.

“Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission. Additionally, pre-clinical and clinical data have shown Molnupiravir to be active against the most common SARS-CoV-2 variants.”

Interim analysis of trial data has indicated that the antiviral cuts the risk of hospitalization and death by approximately 50%. 7.3% of patients who received the drug were hospitalized or died during the trial, versus 14.1% of those who received a placebo. Additionally, 0 deaths were reported in patients who received the antiviral, compared to 8 deaths in those who received a placebo, by day 29 of the trial. The trial was stopped after observing such positive results.

Molnupiravir has been compared to Tamiflu, an antiviral used to treat and prevent influenza.