A proposed Emergency Use Authorization (EUA) for molnupiravir, an investigational oral antiviral drug discovered at Emory, received a favorable vote from a Food and Drug Administration (FDA) advisory committee this week.
Members of the FDA’s Antimicrobial Drugs Advisory Committee voted 13-10 on Tuesday, Nov. 30, in favor of the treatment, which is proposed for use with adult patients with mild to moderate COVID-19 who are at risk for severe disease or hospitalization.
The vote brought an antiviral pill against COVID-19 — one that could be effective against multiple SARS-CoV-2 viral variants and potentially widely accessible — a step closer to reality in the United States. The drug has been conditionally authorized in the United Kingdom.
Pharmaceutical company Merck and its partner Ridgeback Biotherapeutics have been testing molnupiravir in clinical trials, after licensing it from Drug Innovation Ventures at Emory (DRIVE) last year. Merck applied for an EUA in October, after announcing that molnupiravir can significantly reduce the risk of hospitalization or death in non-hospitalized patients with mild to moderate COVID-19. The company recently reported an updated analysis of its Phase 3 clinical trial, which found that molnupiravir reduced the risk of hospitalization and death by 30%.
When the COVID-19 pandemic began, DRIVE scientists repurposed a broad-spectrum antiviral drug, known as EIDD-2801, which was initially developed against other viruses such as equine encephalitis and influenza. Molnupiravir can be provided as a pill in an outpatient setting, which could facilitate distribution. Although other medications such as remdesivir and antiviral monoclonal antibodies have received EUAs from the FDA, they must be delivered by intravenous infusion.
Molnupiravir works by targeting an enzyme the virus needs to make copies of itself and introducing errors into the viral genome.
A full recording of the meeting is here.