UK medicine regulators have approved the first oral antiviral, which is to be taken at home twice daily by patients with at least one risk factor for developing severe Covid.
The Medicines and Healthcare products Regulatory Agency (MHRA) said molnupiravir (brand name Lagevrio) was safe and effective at reducing the risk of hospitalisation and death in those at risk of developing severe disease.
It has been authorised for use in people who have mild to moderate Covid-19 and at least one risk factor for developing severe illness, including obesity, aged over 60 years, diabetes mellitus, or heart disease.
The Government has bought 480,000 doses of the antiviral – which is a twice daily pill – with the first doses expected to arrive by mid-November.
There is as yet no information on how the treatment developed by Merck will be deployed to patients but details will follow in due course, the Department of Health and Social Care said.
Health secretary Sajid Javid said last month that the Government was ‘working to get in place plans for deployment of the treatments, including the delivery of a national study, to collect further data on who would most benefit’.
Molnupiravir works by interfering with the virus’ replication keeping levels low and clinical trial data shows it is most effective in the early stages of infection.
The MHRA said it should be used as soon as possible after a positive Covid-19 test and within five days of symptoms onset.
Dr June Raine, MHRA chief executive, said the decision had been made following a rigorous review of the data by their expert committee and they were satisfied the antiviral was safe and effective.
‘Lagevrio is another therapeutic to add to our armoury against Covid-19. 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.’
Professor Sir Munir Pirmohamed, chair of the Commission on Human Medicines, that independently analysed the trial data said they endorsed the regulatory approval.
‘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%.
‘Based on this and other data that has been carefully reviewed by the Commission and its expert group, it is clear Lagevrio is another safe and effective treatment to help us in our fight against Covid-19.’