The US Food and Drug Administration on Wednesday authorized Pfizer’s antiviral pill, Paxlovid, to treat COVID-19 in high-risk individuals age 12 and older who weigh at least 88 pounds.
This is the first antiviral Covid-19 pill authorized for ill people to take at home before they get sick enough to be hospitalized.
Pfizer Chairman and CEO Albert Bourla made the announcement in a statement on Wednesday.
The statement read, in part, “Today’s authorization 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.
This breakthrough therapy, which has been shown to significantly reduce hospitalizations 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.
“Pfizer stands ready to begin delivery in the U.S. immediately to help get PAXLOVID into the hands of appropriate patients as quickly as possible.”
Paxlovid combines a new antiviral drug named nirmatrelvir and an older one called ritonavir. Last week, Pfizer released updated results that showed the treatment cut the risk of hospitalization or death by 89% if given to high-risk adults within a few days of their first symptoms. If given within the first five days of symptoms, the efficacy was similar: 88%.
In November, the Biden administration announced that it would purchase 10 million treatment courses for $5.295 billion.
A five-day course of Paxlovid includes three pills given twice a day. President Biden said he was encouraged by the “promising data” from Pfizer and said the drug would “mark a significant step forward in our path out of the pandemic.”