COVID antiviral Paxlovid steps closer to full FDA approval
A federal advisory panel recommended Food and Drug Administration approval for Paxlovid on Thursday, more than a year after the agency authorized the antiviral under emergency use.
The Antimicrobial Drugs Advisory Committee said the drug's benefits outweigh the risks when used to treat mild to moderate COVID-19 in adults who are at high risk for severe disease, hospitalization or death.
The FDA typically follows the committee's recommendations and is expected to officially approve Paxlovid.
Made by Pfizer, Paxlovid is a combination of two drugs: ritonavir and nirmatrelvir.
Nirmatrelvir, an oval, pink pill, is a so-called protease inhibitor – the same type of drug that turned HIV into a manageable disease. It stops the SARS-CoV-2 virus from replicating. Ritonavir, a white or off-white pill, boosts the activity of nirmatrelvir.
Paxlovid is given in a five-day course with three pills taken twice a day, with most people feeling better by the second or third day on the drug.
Over 8 million COVID-19 patients in the the U.S. have received Paxlovid since it was first authorized by the FDA emergency use in December 2021.
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Paxlovid not linked to 'rebound' case
One side effect commonly attributed to Paxlovid is "rebound" — testing positive for COVID-19 or symptoms showing up again two to eight days after recovery, typically lasting about three days.
But new evidence suggests COVID-19 rebound may have occurred "as part of the natural progression and resolution of COVID-19 disease," regardless of Paxlovid treatment.
Data also showed Paxlovid reduced the risk of hospitalization and death by more than 80% in high-risk adults who had a previous bout of COVID-19 or never had the disease, and had a 58% reduced risk in those who were vaccinated.
Researchers also found Paxlovid was effective against the omicron variant and related subvariants, which suggests it may be effective against any emerging variants.
However, the data showed those who were not high-risk patients had only 1-2% reduced risk in hospitalization and death with Paxlovid, which authors say may not be worth the risk of potential adverse events from other drug interactions.
There are 143 drugs that are listed to have interactions with Paxlovid, including 37 that are contraindicated, 21 that are recommended to avoid or discontinue use, 49 that are recommended to adjust the dose, and six where monitoring is recommended.
Study trials did not include enough immunocompromised patients to determine whether Paxlovid is recommended for this population, researchers said.
Contributing: Karen Weintraub, USA TODAY. Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
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This article originally appeared on USA TODAY: COVID drug Paxlovid recommended for full FDA approval by expert panel