FDA approves first tablet to treat COVID

Jamie Gambrecht and Amanda Seeley CNN

On Wednesday, the US Food and Drug Administration granted Pfizer’s antiviral drug Paxrovid to treat Covid-19.

This is the first antiviral Covid-19 pill that sick people are allowed to take home before they get sick enough to be hospitalized.

High-risk individuals over the age of 12 who weigh 88 pounds or more and test positive for SARS-CoV-2 are eligible for this treatment and must be prescribed by a doctor.

According to an FDA statement, the pill “should be started as soon as possible within 5 days of the onset of symptoms after the diagnosis of Covid-19.”

Paxlovid is a combination of a new antiviral drug called Nirmatrelvir and an old antiviral drug called ritonavir, given as three tablets given twice daily for 5 days.

Last week, Pfizer released the latest results showing that treatment reduces the risk of hospitalization or death by 89% when given to high-risk adults within days of their first symptoms. When administered within the first 5 days of symptoms, efficacy was similar: 88%.

“Today’s approval of the PAX LOVID is another great example of how science can help us ultimately defeat this pandemic. This pandemic is the life of people around the world, even after two years. This breakthrough treatment, which can be taken at home, significantly reduces hospitalizations and deaths, changes the way COVID-19 is treated and puts significant pressure on the medical and hospital systems. We hope it helps alleviate some of the problems, “Pfizer Chairman and CEO Albert Bula said in a statement. “Pfizer is ready to begin delivery in the United States immediately to get the PAXLOVID into the hands of the right patients as soon as possible.”

In November, the Biden administration announced that it would purchase 10 million treatment courses for $ 5,295 million. Encouraged by “promising data” from Pfizer, President Biden said the drug “takes an important step towards a break from the pandemic.”

He called Paxrovid “a potentially powerful tool in the fight against viruses containing Omicron mutants,” but vaccination and booster shots are “the most important tool needed to save lives.” I emphasized that.

The FDA emphasized in a statement that Paxlovid is not for pre-exposure or post-exposure prophylaxis of Covid-19, but “is not a substitute for COVID-19 vaccination and individual vaccination where boost immunization is recommended.” did.

Separately, Merck has requested an emergency use authorization for its antiviral drug, molnupiravir. It was narrowly recommended by an FDA adviser with 13-10 votes at the end of November, after the data showed a 30% reduction in the risk of hospitalization or death for high-risk adults. This is lower than in previous analyzes, suggesting that the number could be around 50%. The FDA has not announced whether to approve treatment.

Remdesivir, sold under the Veklury brand, is the only antiviral drug approved by the FDA for the treatment of Covid-19. It is given intravenously, not as a tablet that can be taken at home. FDA approves first tablet to treat COVID

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