London, November 4: The UK has approved antiviral COVID-19 drug Lagevrio (molnupiravir) after it was found to be safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate COVID-19 following a stringent review.
The drug is developed by Ridgeback Biotherapeutics and Merck Sharp and Dohme (MSD), Lagevrio 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 UK's Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement on Thursday.
Taking to Twitter, UK Prime Minister Boris Johnson wrote, "Brilliant to hear @MHRAgovuk has approved the world's first antiviral pill for Covid - molnupiravir. Along with the vital protection provided by our vaccines, this treatment can prevent those who are most at risk from becoming seriously ill with Covid." COVID-19 Drug Molnupiravir May Reduce Risk of Hospitalisation and Death in Newly-Diagnosed Patients, Says Health Expert Dr Krishna Reddy Nallamalla.
Based on the clinical trial data, Lagevrio is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible following a positive COVID-19 test and within five days of symptoms onset, the statement added.
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. Such risk factors include obesity, older age, diabetes mellitus, or heart disease, the MHRA said.
"Today is a historic day for our country, as the UK is now the first country in the world to approve an antiviral that can be taken at home for COVID-19. This will be a gamechanger for the most vulnerable and the immunosuppressed, who will soon be able to receive the ground-breaking treatment," the UK's Health and Social Care Secretary Sajid Javid said.
"The UK is leading the way to research, develop and roll out the most exciting, cutting-edge treatments, and my thanks goes to the expert teams at the MHRA and MSD for this triumph, as well as the Antivirals Taskforce who have procured the treatment," he added.
Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said: "In clinical trials, Lagevrio was found to be effective in reducing the risk of hospitalisation or death for at-risk non-hospitalised adults with mild to moderate COVID-19 by 50%." Molnupiravir, COVID-19 Antiviral Pill Cuts Risk of Hospitalisation, Deaths by 50% in Patients, Says Manufacturer.
"Lagevrio is not intended to be used as a substitute for vaccination against COVID-19," Pirmohamed added. Rob Davis, CEO and president of Merck, has said that the first global authorisation of "our COVID-19 antiviral medicine is a major achievement in Merck's singular legacy of bringing forward breakthrough medicines and vaccines to address the world's greatest health challenges".
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