Merck/Ridgeback oral drug molnupiravir enters rolling review in EU

At present, the new crown pneumonia epidemic abroad is still spreading rapidly

Recently, Merck & Co and Ridgeback Biotherapeutics jointly announced that the European Medicines Agency (EMA) has initiated a rolling review of molnupiravir (MK-4482/EIDD-2801), an oral drug under development.

Earlier this month, Merck had submitted an emergency use authorization (EUA) application for molnupiravir to the U.

Molnupiravir is an oral antiviral drug, currently being jointly developed by Merck and Ridgeback Biotherapeutics, and both parties are actively cooperating with regulatory agencies around the world

The regulatory application of molnupiravir is based on the positive results of the interim analysis of the Phase 3 MOVe-OUT clinical trial

Interim analysis showed that compared with placebo, molnupiravir treatment reduced the risk of hospitalization or death by approximately 50%

In terms of safety, the incidence of adverse events in the molnupiravir treatment group and the placebo group was comparable (35% and 40%, respectively)

Molnupiravir is a potent orally administered ribonucleoside analog that can inhibit the replication of a variety of RNA viruses, including the new coronavirus (SARS-CoV-2), which is the pathogen that causes COVID-19

MOVe-OUT (MK-4482-002; NCT04575597) is a global phase 2/3, randomized, placebo-controlled, double-blind, multi-site study.

The phase 3 part of the trial was carried out globally, and patients were randomly divided into 2 groups at a 1:1 ratio, twice a day, oral molnupiravir (800mg) or placebo for 5 days

In the trial, the most common risk factors for poor prognosis of the disease included obesity, advanced age (>60 years), diabetes, and heart disease

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Original source: Merck and Ridgeback Announce Initiation of a Rolling Review by the European Medicines Agency for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of COVID-19 in Adults