Merck Submits Emergency Use Authorization Application to U.S. FDA for Molnupiravir, an Oral Antiviral for Mild-to-Moderate COVID-19 in High-Risk Adults
Oct 13, 2021 02:57
CST Updated
02:57
MSD
Pharmaceutical R&D and Manufacturer
FDA
U.S. Food and Drug Administration
October 13, 2021 /BioonBIOON/ -- Currently, the COVID-19 epidemic overseas continues to spread rapidly. According to Baidu's "Real-Time Novel Coronavirus EpidemicBig DataReport》, as of 01:00 on October 13, 2021, global cumulative confirmed cases`Over 239 million cases`, deaths exceeded 4.876 million.
Recently, MSD (Merck & Co.) announced that it has submitted to the U.S. Food and Drug Administration (FDA) submittedmolnupiravir（MK-4482/EIDD-2801）Emergency Use Authorization (EUA) Application:For the treatment of mild to moderate COVID-19 in adult patients at risk of progressing to severe COVID-19 and/or hospitalization.. molnupiravir is aOral antiviral drugs, currently under joint development by MSD and Ridgeback Biotherapeutics, both parties are actively collaborating with regulatory authorities worldwide to submit applications for emergency use or marketing authorization in the coming months.
This application is based on the Phase 3 MOVe-OUT trial.Clinical trialPositive results from an interim analysis. The trial evaluated the efficacy and safety of molnupiravir in adult patients with mild to moderate COVID-19 at risk of progression to severe COVID-19 and/or hospitalization.
Interim analysis showed,Compared with placebo, molnupiravir treatment reduced the risk of hospitalization or death by approximately 50%. In the molnupiravir treatment group, 7.3% of patients were hospitalized or died from randomization through day 29 (28/385), compared with 14.1% (53/377) in the placebo group, a statistically significant difference (p=0.0012).By day 29, no deaths were reported in the molnupiravir treatment group, whereas 8 deaths were reported in the placebo group.
In terms of safety, the incidence of adverse events was comparable between the molnupiravir treatment group and the placebo group (35% and 40%, respectively). The incidence of drug-related adverse events was also comparable (12% and 11%, respectively); fewer patients in the molnupiravir treatment group discontinued treatment due to adverse events compared with the placebo group (1.3% and 3.4%, respectively).
Chemical structure of molnupiravir (Image source: scinexx.de)
Molnupiravir is a potent, orally administered ribonucleoside analog that inhibits the replication of multiple RNA viruses, including the novel coronavirus (SARS-CoV-2)., which is the pathogen that causes COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission, and has also demonstrated activity in preclinical models of SARS-CoV-1 and MERS.
MOVe-OUT (MK-4482-002; NCT04575597) is a global Phase 2/3, randomized, placebo-controlled, double-blind, multicenter study enrolling patients with laboratory-confirmed mild to moderate COVID-19.Non-hospitalized adult patients (aged ≥18 years), these patients had not received SARS-CoV-2 vaccination, had at least one risk factor associated with adverse disease outcomes, and developed symptoms within 5 days prior to randomization.
The Phase 3 portion of this trial was conducted globally. Patients were randomized in a 1:1 ratio to two groups to receive oral molnupiravir (800 mg) or placebo twice daily for 5 days. The primary efficacy endpoint was to evaluate the efficacy of molnupiravir versus placebo based on the proportion of patients hospitalized and/or who died from randomization through Day 29.
In this trial, the most common risk factors for poor disease prognosis include obesity, advanced age (>60 years),# Diabetes mellitusand heart disease. The Delta, Gamma, and Mu variants accounted for nearly 80% of the baseline viral variants sequenced at the interim analysis. Enrolled patients from Latin America, Europe, and Africa comprised 56%, 23%, and 15% of the study population, respectively. (Bioon.com)