FDA authorizes first pill to treat COVID at home
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Paxlovid. Photo courtesy of Pfizer Inc.
The Food and Drug Administration on Wednesday authorized Pfizer's antiviral pill for the treatment of individuals at high risk of severe illness from COVID-19.
Why it matters: At-home COVID-19 treatments, especially Pfizer's Paxlovid, are seen as possible game-changers for the pandemic. The emergency use authorization comes as the U.S. sees a surge in new COVID-19 cases and hospitalizations largely driven by the Omicron variant.
Driving the news: Pfizer released new data last week confirming Paxlovid reduced the risk of hospitalization or death by 89% in high-risk adults, Axios' Tina Reed reports.
- An interim analysis of a second study of the pill has so far shown a 70% reduction in hospitalization among standard-risk adults, Pfizer said.
- Pfizer also believes the Paxlovid treatment will work well against the Omicron variant because of the way the drug works.
Details: The EUA is for the treatment of mild-to-moderate COVID-19 in adults and some children 12 years and older "who are at high risk for progression to severe COVID-19, including hospitalization or death," the FDA said.
- "Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset," it added.
What they're saying: "Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
- Pfizer chairman and CEO Albert Bourla called the EUA a "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 ... will change the way we treat COVID-19 and hopefully help reduce some of the significant pressures facing our health care and hospital systems," he added in a statement.
President Biden in a statement later Wednesday said the authorization was "a significant step forward in our path out of the pandemic."
- "Today’s action is a testament to the power of science and the result of American innovation and ingenuity."
Between the lines: The pill is most effective when given early in the course of an infection, underscoring the importance of inexpensive, easily accessible COVID-19 tests, including at-home rapid versions, Axios' Bryan Walsh writes.
- Biden on Tuesday said that his administration will make 500 million at-home COVID-19 tests available for free, starting next month.
The big picture: The federal government has ordered enough of Paxlovid to treat 10 million Americans. Biden said Wednesday that over 250,000 treatment courses will be available in January.
- "Recognizing that this pill takes time to make given the complex scientific process, production will ramp up in the months ahead," the president added.
The FDA is also considering whether to authorize Merck and Ridgeback Biotherapeutics' antiviral COVID-19 pill, known as molnupiravir.
- Merck said last month that molnupiravir reduced the risk of hospitalization or death for patients with mild or moderate COVID-19 by about 30%, based on a study of more than 1,400 adults.
- Molnupiravir won a narrow backing from an FDA advisory panel, with some expressing concerns over the drug's effectiveness and safety.
Editor's note: This story has been updated with Biden's statement.
