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FDA Authorizes 1st Antiviral Pill For COVID

A raised metal sign reading PFIZER is attached to the outside of a building. An American flag is reflected in the building's facade.
Pfizer's antiviral pill Paxlovid to treat COVID-19 was authorized by the Food and Drug Administration Wednesday.
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In a highly anticipated decision, the Food and Drug Administration authorized the first antiviral pill to treat COVID-19 at home.

The pill, called Paxlovid, is made by Pfizer. It's taken twice a day for five days in combination with a second medicine, ritonavir, which is a generic antiviral.

"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 Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research. "This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19."

The Pfizer treatment could help keep people who are infected with COVID-19 from getting so sick that they need to be hospitalized.

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The results from a Pfizer study involving more than 2,200 people at high risk for developing serious COVID-19 found Paxlovid reduced the risk of hospitalization or death by 89%, compared with a placebo, when taken within three days of first symptoms of illness. When taken within five days, the drug reduced the risk of hospitalization and death by 88%.

Early results from another Paxlovid study showed a 70% reduction in hospitalization risk among several hundred people at lower risk for severe disease.

The federal government has a contract with Pfizer to buy 10 million courses of the treatment for $5.3 billion. But initial supplies of Paxlovid will be limited. The company said it has tens of thousands of courses ready to ship from a Memphis supply hub.

The FDA is also weighing a COVID-19 pill from Merck and Ridgeback Biotherapeutics that is also taken twice a day for five days.

There's more of the Merck drug to go around. Merck says it will have 10 million packs available by the end of the month.

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But the effectiveness of the Merck COVID pill may make it less attractive. An interim analysis of a clinical study of the drug found that molnupiravir cut the risk of hospitalization or death in half. However, the final study analysis released a couple of days before a public meeting of adviser to the FDA, found only a 30% reduction in the risk of hospitalization or death. And FDA advisers raise concern about the possibility the drug could cause birth defects.

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