Molnupiravir Presentation Posted for U.S. FDA Review

The U.S. FDA published the agenda for the Center for Drug Evaluation and Research Antimicrobial Drugs Advisory Committee meeting scheduled for November 30, 2021, regarding Molnupiravir, an oral antiviral treatment.

This new treatment significantly reduces the risk of hospitalization or death related to COVID-19 through Day 29 by approximately 50%.

New Jersey-based Merck & Co., Inc. is presenting information regarding EUA #000108, which states 'the totality of data to date supports the favorable benefit/risk profile of MOV for the proposed authorized use under Emergency Use Authorization (EUA).'

This document summarizes the results of the development program conducted to support the use of molnupiravir (MOV, MK-4482) to treat mild to moderate COVID-19 in adults who are at risk for progressing severe COVID-19 and/or hospitalization.

MOV is an orally administered antiviral for the treatment of COVID-19. MOV inhibits the replication of SARS-CoV-2, with similar activity across variants of concern.

It has a high barrier to resistance, with no evidence of resistance development to MOV in nonclinical or clinical studies to date.

The proposed dosage is MOV 800 mg (administered as four 200 mg capsules) taken every 12 hours (Q12H) with or without food for five days.

Treatment should be started as soon as possible after a diagnosis of COVID-19 and within five days of symptom onset.

The safety of MOV was evaluated in approximately 600 participants who received the proposed dose and duration of treatment (MOV 800 mg Q12H for five days) across the comprehensive clinical development program.

MOV was well tolerated with an acceptable safety profile and no organ toxicities observed in clinical studies.

The nonclinical (i.e., pharmacology, metabolism, and toxicity) and clinical (i.e., safety, efficacy, and virology) assessments summarized in this document demonstrate that MOV addresses a significant unmet medical need for safe and effective oral agents to treat COVID-19, says Merck.