Joe Raedle/Getty Images/FILE
Paxlovid is now approved for the treatment of mild to moderate Covid-19.
The U.S. Food and Drug Administration on Thursday fully approved the antiviral drug Paxlovid for the treatment of mild to moderate Covid-19 in adults at risk of severe infections.
Paxlovid was available to adults and teens in the United States under an emergency use authorization, or EUA, that strictly limited how the medication could be prescribed.
The FDA’s standards for full approval are stricter than those for an EUA.
“Today’s approval demonstrates that Paxlovid has met the agency’s rigorous standards for safety and effectiveness, and remains an important treatment option for people at high risk of progression to severe COVID-19, 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 gives doctors more latitude in using the drug. For example, they may choose to prescribe a longer course of treatment if a person shows signs that the 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 for prevention of infection before or after exposure.
Paxlovid is a combination of two drugs – nirmatrelvir and ritonavir – taken together as pills for five days within the first five days of a person’s Covid-19 symptoms.
In the clinical trials leading up to the drug’s approval, Paxlovid reduced the risk of hospitalization or death by 86% compared to a placebo in people who were at risk of serious disease due to their age or an underlying health condition.
The FDA says 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 types of medications. For that reason, it will come with a black box warning about its potential to interfere with other drugs.
Today’s approval only covers adult treatment, but the FDA says the drug will still be available to adolescents ages 12 to 18 with emergency use authorization.