US grants final approval to its first oral antiviral to treat COVID

On Thursday, May 25th, the United States Food and Drug Administration (FDA) announced the final approval of the first oral pill to treat COVID-19, Paxlovid, which was previously authorized for emergency use.

Their statement specified that the oral antiviral Paxlovid is the fourth drug and the first oral antiviral pill approved for the treatment of COVID-19 in adults.

The benefit of Paxlovid has been demonstrated in patients with prior immunity to the virus that causes COVID-19. The FDA recommends its use when the infection is mild to moderate, for adults at high risk of disease progression.

The risk of COVID-related hospitalization or death from any cause during the 28 days of follow-up was 0.2 percent among the 490 people treated with Paxlovid, compared to 1.7 percent among the 479 who received placebo.

“Today’s approval demonstrates that it has met the FDA’s rigorous standards for safety and efficacy and continues to be an important treatment option for people at high risk of progressing to severe COVID, including those with prior immunity,” said Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research.

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