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Molnupiravir: First Approval
1Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. dru@adis.com.
Abstract:
Molnupiravir (Lagevrio®) is an orally-administered antiviral prodrug that inhibits replication of RNA viruses through viral error induction. It is being developed by Merck and Ridgeback Biotherapeutics for the prevention and treatment of Coronavirus disease 2019 (COVID-19). Molnupiravir received its first approval on 4 November 2021 in the UK for the treatment of mild to moderate COVID-19 in adults with a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostic test and who have at least one risk factor for developing severe illness. Molnupiravir is filed for approval and has emergency use authorization for the treatment of COVID-19 in several countries, including the USA, Japan and those in the EU. This article summarizes the milestones in the development of molnupiravir leading to this first approval for COVID-19.
Insights
Molnupiravir, an oral antiviral prodrug, was approved in the UK for treating mild to moderate COVID-19 in at-risk adults. It works by inducing viral errors to inhibit RNA virus replication, marking a significant development milestone.
Area of Science:
- Virology
- Pharmacology
- Infectious Diseases
Background:
- Molnupiravir is an orally-administered antiviral prodrug designed to inhibit RNA virus replication.
- It functions by inducing errors during viral RNA replication, a novel mechanism of action.
- Developed by Merck and Ridgeback Biotherapeutics, it targets the prevention and treatment of COVID-19.
Purpose of the Study:
- To summarize the key milestones in the development of molnupiravir.
- To highlight the drug's journey leading to its first regulatory approval for COVID-19 treatment.
Main Methods:
- Review of development milestones for molnupiravir.
- Analysis of regulatory submissions and approvals.
- Summary of the drug's mechanism of action and target indications.
Main Results:
- Molnupiravir received its first approval in the UK on November 4, 2021.
- The approval is for treating mild to moderate COVID-19 in adults with risk factors for severe illness.
- The drug has emergency use authorization or is filed for approval in multiple countries, including the USA, Japan, and EU nations.
Conclusions:
- Molnupiravir represents a significant advancement in oral antiviral therapies for COVID-19.
- The drug's development and approval milestones underscore its potential role in managing the pandemic.
- Further regulatory reviews and market access are anticipated globally.
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