The United States Food and Drug Administration (FDA) announced Thursday the final approval of the first oral pill to treat Covid-19, the Paxovidhitherto authorized for emergency use.
His statement specified that the oral antiviral Paxlovid is the fourth medication and the first antiviral pilll oral that has been approved for the treatment of Covid-19 in adults.
The benefit of Paxlovid was demonstrated in patients with previous immunity to the virus that causes covid. The FDA recommends its use when the infection is of mild to moderatefor adults at high risk of severe disease.
The risk of covid-related hospitalization or death from any cause during the 28-day follow-up was 0.2% among 490 people treated with Paxlovid, compared with 1.7% among 479 who received placebo.
“Today’s approval demonstrates that it has met the agency’s rigorous safety and efficacy standards and remains an important treatment option for people at high risk of progression to severe COVID-19, including those with prior immunity,” he said. in the note the director of the FDA’s Center for Drug Evaluation and Research, Patrizia Cavazzoni.