Merck submits FDA EUA application for oral antiviral medication

Oct. 12, 2021

Merck has officially submitted an emergency use authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for molnupiravir, an investigational oral antiviral medicine, for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.

Molnupiravir is being developed by Merck in collaboration with Ridgeback Biotherapeutics.

Last week, the companies released results from a planned interim analysis from a Phase 3 clinical trial, that evaluated molnupiravir in non-hospitalized adult patients with mild-to-moderate COVID-19 who were at risk for progressing to severe COVID-19 and/or hospitalization. At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377). Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo.

Similarly, AstraZeneca submitted an EUA request to the FDA earlier this month for AZD7442, the company’s long-acting antibody combination for protection against symptomatic COVID-19.

In August 2021, AstraZeneca announced high-level results from the PROVENT pre-exposure prophylaxis trial which showed AZD7442 reduced the risk of developing symptomatic COVID-19 by 77%, compared to placebo. Importantly, the trial population included people with co-morbidities and who may be in need of additional protection from SARS-CoV-2 infection.

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