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news.The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has started a rolling review of molnupiravir (MK-4482 and EIDD-2801), an investigational oral antiviral medicine, to treat adult patients with Covid-19.
EMA will assess the quality, safety and effectiveness data of molnupiravir. Credit: © 2009-2021 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has started a rolling review of molnupiravir (MK-4482 and EIDD-2801), an investigational oral antiviral medicine, to treat adult patients with Covid-19.
Molnupiravir, which was developed by Merck Sharp & Dohme together with Ridgeback Biotherapeutics, inhibits the replication of SARS-CoV-2 virus.
The rolling review is based on preliminary data obtained from laboratory (non-clinical data) and clinical studies, which suggest that the medicine may reduce the replication of SARS-CoV-2 virus and prevents hospitalisation or death in Covid-19 patients.
As part of the procedure, the EMA will assess the quality, safety and effectiveness data of the medicine as it becomes available.
This process will continuing until Merck has enough evidence to submit a marketing authorisation application.
Additionally, the company has also submitted an application to seek authorisation from the US Food and Drug Administration (FDA) and is working to submit applications to other regulatory agencies across the world.
Merck Research Laboratories executive vice president and president Dean Li said: “This application to the EMA is another step in our efforts to bring molnupiravir forward to patients globally.
“We believe that molnupiravir will be an important addition to the range of public health tools to fight Covid-19 – including the vaccines developed by the research-based pharmaceutical industry, which remain essential and are the first-line of defense against this pandemic.”
The submission is based on the positive data obtained from the randomised, placebo-controlled, double-blind, multi-site Phase 3 MOVe-OUT clinical trial, which was conducted in 775 patients.
The trial assessed the efficacy of molnupiravir in non-hospitalized patients with mild-to-moderate Covid-19.
It showed that the medicine, which was administered twice daily, reduced the hospitalisation risk or death by 50%.
