MHRA Approves First Oral Antiviral for COVID-19

Tim Locke

November 04, 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the first oral antiviral for COVID-19.

The regulator said molnupiravir (Lagevrio) from Ridgeback Biotherapeutics and Merck Sharp & Dohme (MSD), 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 so is recommended as soon as possible after a positive COVID-19 test, and within 5 days of symptoms onset. 

Eligible patients will include those with at least one risk factor for developing severe illness, including being over-60, obesity, diabetes, or 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.

COVID-19 Armoury

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."

Winter Pressure

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 COVIDtreatments, 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."

Commenting via the Science Media Centre, Professor Penny Ward, independent pharmaceutical physician, visiting professor in pharmaceutical medicine, King’s College London, said: "The announced price of this drug in the US is $713 (about £520), making it more than 20 times more expensive than Tamiflu which the UK stockpiled for use in an influenza pandemic.

"The NHS supply price has not been announced. Its manufacturer, Merck, has announced plans to produce 10 million courses of the drug in 2021 which - given the likely worldwide demand - is an extremely limited supply. Other antiviral treatments already approved in the UK include the intravenous monoclonal antibody combination from Regeneron, which is limited to hospital use, and remdesivir, another intravenous agent which was recently shown to be effective in an outpatient setting if started within 5 days of symptom onset and given for 3 days.

"Perhaps the NHS might also investigate whether a 3 day course of molnupiravir is as effective as a 5 day course, in which case the limited supply available might be stretched further."

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