US pharmaceutical firm Merck (MRK) is set for a bumper windfall after the UK became the first country to approve its pill designed to treat symptomatic COVID-19 infections.
The company said on Thursday that the Medicines & Healthcare Products Regulatory Agency (MHRA), the UK's medicines regulator granted authorisation for use of its oral tablet, called molnupiravir.
It will be given twice a day to vulnerable patients, who have recently been diagnosed with COVID-19, under the trademark Lagevrio. It can be taken at home within five days of infection.
During its clinical trials, the drug cut the risk of hospitalisation and death by half for people with with mild-to-moderate symptoms.
Data from 775 patients showed that none of the participants had died during the first 29 days of the study, compared to eight who received a placebo.
"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," health secretary Sajid Javid said in a statement.
Regulators in the European Union (EU), and in the US, are still evaluating the drug, with the latter scheduled to meet later this month. Merck added that it was also working to submit applications to other regulatory agencies.
However, it has recently seen a rise in demand from governments after its successful phase three study was published last month.
The UK has snapped up almost half a million courses of molnupiravir, and the US has purchased 1.7 million at a total cost of $1.2m (£880m), or $700 for each patient.
Australia, Singapore and South Korea have also made purchase agreements, setting the company up for a bumper revenue increase. The UK government did not disclose how much its initial contract was worth.
Shares were more than 3% higher in pre-market trading on the back of the news.
It comes just days after Merck revealed that it expects the pill to generate up to $7bn in global revenue by the end of 2022.
Robert Davis, chief executive, said: "In pursuit of Merck's unwavering mission to save and improve lives, we will continue to move with both rigour and urgency to bring molnupiravir to patients around the world as quickly as possible."
Britain was also the first country in the world to approve Pfizer coronavirus vaccine last December after it had been tested in a large clinical trial. UK regulators likewise granted emergency-use authorisation.
According to official figures, more than five million people have died of COVID-19 globally. The UK recorded 41,229 cases on Wednesday, and 217 deaths within 28 days of a positive test.
June Raine, chief executive of the MRHA, said the treatment was "another therapeutic to add to our armoury against COVID-19".
"It is the world's first approved antiviral for this disease that can be taken by mouth rather than administered intravenously," she said.
"This is important, because it means it can be administered outside of a hospital setting, before COVID-19 has progressed to a severe stage."
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