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FDA authorizes first oral antiviral to treat COVID-19

On Wednesday, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Paxlovid tablets, Pfizer’s nirmatrelvir and ritonavir tablets, packaged for oral use, for the treatment of treatment of mild to moderate coronavirus disease in adult and pediatric patients 12 years of age or older who weigh 88 pounds, test positive for COVID, and are at high risk for progression to severe COVID-19, including hospitalization or death.

Paxlovid is available by prescription only and should be started as soon as possible after COVID-19 diagnosis and within five days of symptom onset.

“Today’s authorization introduces the first treatment for COVID-19 in oral pill form — a huge step forward in the fight against the global pandemic,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drugs. this bridge. Evaluation and Research. “This authorization provides a new tool to combat COVID-19 at a critical time in the pandemic as new variants emerge and holds the promise of making antiviral treatment more accessible to patients.” patients at high risk of developing severe COVID-19.”

Paxlovid is not authorized for pre- or post-exposure prophylaxis to COVID-19 or to initiate treatment in persons requiring hospitalization due to severe or severe COVID-19. Paxlovid is not a substitute for vaccination in those for whom COVID-19 vaccination and a booster dose are recommended.

The FDA has approved one vaccine and authorized others to prevent COVID-19 and serious clinical outcomes associated with COVID-19 infection, including hospitalization and death. The FDA urges the public to get vaccinated and get a booster shot if eligible. Learn more about FDA-approved or authorized COVID-19 vaccines.

Paxlovid includes nirmatrelvir, which inhibits a SARS-CoV-2 protein to prevent the virus from replicating, and ritonavir, which slows the breakdown of nirmatrelvir to help it stay in the body for longer at higher concentrations. Paxlovid is taken as three tablets (two nirmatrelvir and one ritonavir), taken together twice daily for five days, for a total of 30 tablets. Paxlovid should not be used for longer than five consecutive days.

Issuing an EUA is different from FDA approval. In determining whether to issue an EUA, FDA reviews the totality of available scientific evidence and carefully balances any known or potential risks with any known or potential product benefits.

Based on FDA’s review of all available scientific evidence, the agency has determined that Paxlovid is reasonably believed to be effective for the treatment of mild to moderate COVID-19 in authorized patients. is reasonable. The agency has also determined that the known and potential benefits of Paxlovid, when used in accordance with the terms and conditions of the license, outweigh the potential and known risks of the product.

There are no appropriate, approved and available alternatives to Paxlovid for the treatment of COVID-19.

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https://www.tampafp.com/fda-authorizes-first-oral-antiviral-for-treatment-of-covid-19/ FDA authorizes first oral antiviral to treat COVID-19

DUSTIN JONES

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