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Merck's rolling submission of molnupiravir oral treatment to COVID-19 to Health Canada

 Last Update: 2021-08-28
 Source: Internet
 Author: User

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

Recently, Merck announced that it has initiated the rolling submission of molnupiravir (MK-4482/EIDD-2801) to Health Canada

According to the interim order of Health Canada, the rolling submission process can be accepted, allowing late-stage clinical trials to review early safety, quality, and efficacy data

The Phase 2 interim results of the Phase 2/3 MOVe-OUT clinical trial were announced at the European Conference on Clinical Microbiology and Infectious Diseases (ECCMID) in July this year.

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 an ongoing phase 2/3, randomized, placebo-controlled, double-blind, multi-site study, confirmed by laboratory testing as COVID-19 and before randomization It was carried out in non-hospitalized adult patients (age ≥18 years) who developed symptoms within 5 days to evaluate the efficacy, safety and pharmacokinetics of oral molnupiravir

The trial plans to recruit 1,850 patients with mild or moderate COVID-19

Original source: Merck Canada Initiates Rolling Submission to Health Canada for Molnupiravir, an Investigational Oral Therapeutic Agent for the Treatment of COVID-19

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