A “game-changing” antiviral pill that is part of the AGILE Coronavirus Drug Testing Initiative has been approved for use in the UK.
After a stringent review of available scientific evidence, the Medicines and Healthcare products Regulatory Agency (MHRA) has said molnupiravir is safe and effective at reducing the risk of hospital admission and death in people with mild to moderate COVID who are at extra risk from the virus.
Developed by Ridgeback Biotherapeutics and Merck Sharp & Dohme (MSD), molnupiravir works by interfering with the virus’ replication. This prevents it from multiplying, keeping virus levels low in the body and therefore reducing the severity of the disease.
The AGILE Clinical Trial Platform evaluated the safety and optimal dose of molnupiravir in participants with early symptomatic infection in a Phase I trial. Crucially, this data confirmed that the dosage used in Merck and Ridgeback’s Phase III trial was safe and well tolerated. The AGILE team is currently carrying out further Phase II trials to determine the ability of molnupiravir to reduce serious complications of COVID-19.
Professor Saye Khoo, Chief Investigator for AGILE at the University of Liverpool, said: “The licensing of molnupiravir marks a new chapter in our fight against COVID. It is the first of a growing number of compounds with antiviral activity, able to be given as tablets to people with early infection, in order to prevent progression, hospitalisation and death. This is a game-changer and heralds a new era of antiviral drugs which are easy to administer, effective, affordable and scalable for global access.”
Molnupiravir has been authorised for use in people who have mild to moderate COVID-19 and at least one risk factor for developing severe illness. Health and Social Care Secretary Sajid Javid said the government and NHS are working quickly to set out plans to deploy it to patients through a national study as soon as possible.
AGILE is a ground-breaking collaboration between researchers from the University of Liverpool, the NIHR Southampton Clinical Trials Unit at the University of Southampton, Liverpool School of Tropical Medicine, NIHR Liverpool and Broadgreen Clinical Research Facility at the Royal Liverpool University Hospital, University of Cambridge and the UK Clinical Research Facility Network.
Here are some articles about this from the media:
BBC – Molnupiravir: First pill to treat Covid gets approval in UK
The Guardian – UK first to approve oral antiviral molnupiravir to treat Covid
Reuters – UK to roll out COVID-19 antiviral drug trial this month
The Washington Post – Britain authorizes Merck’s molnupiravir
For more information, please visit https://www.agiletrial.net/