The Food and Drug Administration (FDA), a United States agency similar to Anvisa, fully approved this Thursday (25) the antiviral drug Paxlovid for the treatment of Covid-19, in mild to moderate conditions, in adults at risk of serious infections.
Paxlovid was available to adults and adolescents in the United States under an emergency use authorization, which strictly limited how the drug could be prescribed.
The FDA’s standards for full approval are more stringent than those for an emergency authorization.
“Today’s approval demonstrates that Paxlovid has met the agency’s rigorous safety and efficacy standards and that it remains an important treatment option for people at high risk of progression to severe Covid-19, including those with prior immunity,” said Patrizia Cavazzoni , director of the FDA’s Center for Drug Evaluation and Research, in a press release.
Full approval will give doctors more freedom to use the drug. For example, they may choose to prescribe a longer course if a person shows signs that their infection may come back, a phenomenon called rebound.
The FDA says Paxlovid should only be used to treat Covid-19. It should not be used as a preventive measure pre-exposure or post-exposure to infection.
Paxlovid is a combination of two drugs — nirmatrelvir and ritonavir — that are taken together as pills for five days within the first five days of a person’s Covid-19 symptoms.
In clinical trials leading to approval, Paxlovid reduced the risk of hospitalization or death by 86% compared with placebo in patients at risk of serious illness due to age or an underlying health condition.
The FDA says Paxlovid is the fourth drug and the first pill to be approved for the treatment of Covid-19.
It is difficult for some people to take it because it has interactions with many other types of medications. For that reason, it will come with a black box warning of its potential to interfere with other drugs.
Today’s approval only covers the treatment for adults, but the FDA says the drug will still be available for teenagers ages 12 to 18 under an emergency use authorization.
Source: CNN Brasil
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