The UK national medicines regulator, the MHRA, announced on Nov. 4 that the antiviral Lagevrio (molnupiravir) had been authorised to treat mild to moderate COVID-19—in those with other risk factors, such as obesity, diabetes, or those over 60 years old.
“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,” said UK health secretary Sajid Javid 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.
“This antiviral will be an excellent addition to our armoury against COVID-19.”
The drug, from Ridgeback Biotherapeutics and Merck Sharp & Dohme (MSD), works by interfering with the virus’s replication.
It prevents the virus from multiplying, keeping levels low in the body and therefore reducing the severity of the disease.
The MHRA said the drug should be taken as soon as possible following a positive COVID-19 test and within the first five days.
The UK department of health said in a statement, “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 (>60 years), diabetes mellitus, or heart disease.”
The government announced last month that it had secured 480,000 courses of molnupiravir after a study published by the manufacturer found it cut the rate of hospital admission and death by 50 percent in mild-to-moderately ill patients who had at least one risk factor for the disease.
That study was an interim clinical trial, as yet not peer-reviewed, on 775 patients who had recently caught the virus.
7.3 percent of those given the drug were hospitalised, compared with 14.1 percent who received a placebo, according to a press statement from MSD.
Among those who were given the drug in the trial there were no deaths. Eight of those who received the placebo died.
The head of the UK’s Commission on Human Medicines said he had reviewed the data and endorsed the MHRA’s regulatory approval.
MSD has already made agreements to supply 1.7 million courses to the U.S. government, pending approval from the EUA or FDA, at a cost of roughly $1.2 billion.
Each course of the drug costs around $700 (£513).
Other countries, including Singapore, South Korea, and Australia have made similar purchase agreements.
MSD said it plans to use a tiered pricing approach based on country income.
Rival drug manufacturer Pfizer has started trials of two different antiviral tablets. Swiss company Roche is also working on an antiviral.
PA contributed to this report