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Paxlovid is now approved for the treatment of mild to moderate Covid-19.
CNN –
The U.S. Food and Drug Administration on Thursday fully approved the antiviral drug Paxlovid to treat mild to moderate Covid-19 in adults at risk of serious infections.
Paxlovid was available in the United States for adults and adolescents under an Emergency Use Authorization (EUA) that strictly restricted the drug’s prescription.
The FDA’s standards for full approval are stricter than those for an EUA.
“Today’s approval demonstrates that Paxlovid meets the agency’s rigorous safety and efficacy standards and that it remains an important treatment option for people at high risk of developing severe COVID-19 disease, including those with prior immunity,” said Dr . Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a press release.
Full approval would give doctors more leeway in using the drug. For example, they may decide to prescribe a longer cycle if a person is showing signs that the infection might 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 pre- or post-exposure prevention of infection.
Paxlovid is a combination of two drugs – nirmatrelvir and ritonavir – taken together as pills for five days within the first five days of the onset of Covid-19 symptoms.
In the clinical trials that led to the drug’s approval, Paxlovid reduced the risk of hospitalization or death by 86% compared with placebo in people who were at risk of developing a serious disease because of age or an underlying medical condition.
According to the FDA, Paxlovid is the fourth drug and first pill approved to treat Covid-19.
It is difficult for some people to take because it interacts with many other medications. For this reason, it comes with a black box warning indicating that it may interact with other drugs.
Today’s approval only covers treatment in adults, but the FDA says the drug will continue to be available to youth ages 12 to 18 under an emergency use authorization.