MHRA approves first COVID-19 antiviral that can be taken at home
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the first oral antiviral for the treatment of COVID-19 at home.
The antiviral Lagevrio (molnupiravir), is “safe and effective” at reducing the risk of hospitalisation or death in people “with mild to moderate COVID-19 who are at increased risk of developing severe disease”, the MHRA announced today (November 4).
Developed by the US drug companies Merck, Sharp & Dohme (MSD) and Ridgeback Biotherapeutics, it is the first antiviral medication for COVID-19 that can be taken as a pill rather than given intravenously.
Lagevrio is a prescription-only medicine (POM), the MHRA clarified to C+D.
The DH and the NHS will clarify “in due course” how this medicine will be deployed to patients, the MHRA added in its statement.
Sir Munir Pirmohamed, chair of the Commission on Human Medicines, said that Lagevrio was found in clinical trials “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 evidence and “other data that has been carefully reviewed by the commission and its expert group”, Lagevrio is “another safe and effective treatment to help us in our fight against COVID-19,” he added.
Antiviral to be deployed nationally “as soon as possible”
The antiviral 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 as obesity, being over the age of 60, diabetes or heart disease, the MHRA said.
The antiviral should be taken as soon as possible following a positive COVID-19 test and “within five days of symptoms onset”, the MHRA added. Patients should take the antiviral “exactly” as indicated by their doctor or pharmacist, according to the patient information leaflet – which points at a recommended dose of four 200mg capsules, every 12 hours for five days.
Lagevrio is not intended to be used as a substitute for vaccination against COVID-19, the MHRA stressed.
MHRA chief executive Dr June Raine said: “[The drug is] 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.
The public “can trust that the MHRA has conducted a robust and thorough assessment of the data”, she stressed.
Full clinical trial results “expected in 2022”
Commenting on the announcement, health secretary Sajid Javid said in a statement: “We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible.”
A Welsh Government spokesperson told C+D: “We welcome the announcement by [the] MHRA that molnupiravir has been approved for use in the UK.
“The full clinical trial results are expected in 2022, which will provide a clearer indication of the likely benefit for those at risk of COVID-19. The UK Government intends to use molnupiravir initially through a national study that will prioritise those who are most high-risk, including those who are immunocompromised, and this will include patients in Wales.”
They added: “We are working with Health and Care Research Wales to support the UK-wide study and other clinical trials of medicines that may be of benefit in the treatment of COVID-19.
“Vaccines remain the best way that we can protect ourselves this winter and it is important that people come forward when they are invited to have their COVID-19 and flu vaccinations.”
C+D has also approached the Scottish government and Health and Social Care Board in Northern Ireland for comment.
Earlier this year, UK pharmacies were told to maintain stock levels of inhaled budesonide to meet routine use as well as to fulfil off-label prescriptions for the treatment of COVID-19.
The message was sent via the central alert system (CAS) after findings from the PRINCIPLE trial had shown that early treatment with inhaled budesonide shortens recovery times from COVID-19 in patients over 50 who were treated with it at home or in other community settings.
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