The MHRA has found the antiviral to be safe and effective following a rigorous review of the evidence
The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the first oral antiviral for COVID-19.
The regulator said molnupiravir (Lagevrio) is safe and effective at reducing the risk of hospitalisation and death in mild-to-moderate COVID-19.
The drug is said to be most effective early in the disease; it is recommended as soon as possible after a positive COVID-19 test, and within 5 days of symptom onset. Eligible patients will include those with at least one risk factor for developing severe illness, including: being over 60 years old; obesity; diabetes; and heart disease. The regulator stressed the drug should not be seen as a substitute for vaccination.
The way the medication will be deployed is yet to be announced by the Government and the NHS.
Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said in a statement: ‘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.’
MHRA Chief Executive, Dr June Raine, said: ‘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.
‘With no compromises on quality, safety, and effectiveness, the public can trust that the MHRA has conducted a robust and thorough assessment of the data.’
Commenting, Professor Stephen Powis, NHS England National Medical Director, said: ‘Once again, the NHS will be able to lead the world in protecting millions from COVID-19 through both its world leading vaccination programme, and researching and implementing the latest COVID treatments, particularly as we head into one of the most challenging winters ever.
‘The NHS stands ready to support the planned study on molnupiravir and other antivirals in patients at higher risk of complications, and to provide wider roll out if it is shown to be clinically- and cost-effective in reducing hospitalisations and death.’
This article originally appeared on Medscape, part of the Medscape Professional Network.
Lead image: carballo/stock.adobe.com
Image 1: carballo/stock.adobe.com