Paxlovid, the antiviral Coronavirus (COVID-19) pill developed by US drugs giant Pfizer Inc (NYSE:PFE), was authorised by the US Food & Drug Administration (FDA).
The FDA said the drug should be initiated as soon as possible after the diagnosis of COVID-19 and within five days of the onset of symptoms.
The pill is intended for high-risk individuals aged 12 or older who weigh at least six stone four pounds (88 lbs or just under 40 kilograms) who have tested positive for COVID-19. The pill will need to be prescribed by a doctor.
Pfizer claims the pill cuts the risk of hospitalisation or death from the effects of the virus by 89% in high-risk adults within a few days of symptoms becoming evident.
"Today's authorisation of PAXLOVID represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world,” said Albert Bouria, who is chairman and chief executive officer of Pfizer.
“This breakthrough therapy, which has been shown to significantly reduce hospitalisations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems," he added.
The authorisation by the FDA means Pfizer can start marketing the pill in the USA.
The FDA said the pill "is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended."
The US government has ordered 10mln packets of the pills at a cost of US$5.3bn. The first 265,000 will be delivered next month with the rest due by late summer, a White House COVID-19 coordinator told a press conference.
Another US drugs giant, Merck, has an antiviral pill of its own on the runway, called molnupiravir. It is pressing for the FDA to fast-track authorisation of the pill although data indicates it is not as efficacious as the Pfizer pill. Data published at the end of November indicated it cuts the risk of hospitalisation or death by 30% among high-risk adults.