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Britain's health authorities on Thursday announced the approval of the first antiviral pill to treat Covid-19. Authorities disclosed that Lagevrio (molnupiravir) is safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate infection who are at increased risk of developing severe disease.
The Medicines and Healthcare products Regulatory Agency (MHRA) made the announcement following a rigorous review of the pill's safety, quality and effectiveness by the United Kingdom's regulator and the government's independent expert scientific advisory body, the Commission on Human Medicines, making it the first oral antiviral for the treatment of Covid-19 to be approved.
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Developed by Ridgeback Biotherapeutics and Merck Sharp & 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, health officials said.
Based on the clinical trial data, Lagevrio is most effective when taken during the early stages of infection; the MHRA recommends its use as soon as possible following a positive Covid-19 test and within five days of the onset of symptoms.
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, including senior citizens who are 60 years of age, diabetes mellitus, or heart disease.
The UK's Health Secretary Sajid Javid 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 is leading the way to research, develop and roll out the most exciting, cutting-edge treatments, and my thanks go 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.
Javid said the antiviral would be an addition to Britain's armoury against the virus.
June Raine, MHRA Chief Executive, added: "Following a rigorous review of the data by our expert scientists and clinicians, we are satisfied that Lagevrio (molnupiravir) is safe and effective for those at risk of developing severe Covid-19 disease and have granted its approval".
"Lagevrio is another therapeutic to add to our armoury…It is also the world's first approved antiviral for this disease that can be taken by mouth rather than administered intravenously. This is important, because it means it can be administered outside of a hospital setting, before Covid-19 has progressed to a severe stage," Raine added.
The officials added that Lagevrio is not intended to be used as a substitute for vaccination against Covid-19.
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