When Will New COVID-19 Antivirals Be Approved in the U.S.?


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When a young, healthy person in the U.S. catches COVID-19, there’s not much they can do except stay home and rest. The antiviral drug Paxlovid is widely available, but it’s only approved for people at high risk of severe disease, such as older adults and people with underlying conditions. The U.S. Food and Drug Administration (FDA) hasn’t approved any drugs that can treat COVID-19 among people who are unlikely to get very sick or die, but nonetheless would like some relief from their symptoms.

These drugs do exist, though. Antivirals currently available overseas seem to be effective at shortening the length and treating the symptoms of mild-to-moderate cases of COVID-19—but it’s anyone’s guess if and when they’ll make the jump to the U.S. market.

A study published in the New England Journal of Medicine in January showed promising results associated with the drug simnotrelvir, which is made by Simcere Pharmaceutical and is currently available in China under the brand name Xiannuoxin. People who took simnotrelvir within three days of developing COVID-19 recovered faster than people who took a placebo, the researchers found. Most of the roughly 1,100 people in the study were young and fully vaccinated and half did not have any specific risk factors for serious disease, which suggests simnotrelvir could work well across much of the general population.

It’s unclear whether Simcere is seeking FDA approval; representatives from the company did not respond to TIME’s requests for comment about if and when it may apply.

At the moment, the drug with perhaps the best shot at cracking the U.S. market seems to be the antiviral ensitrelvir, which is made by the pharmaceutical company Shionogi & Co., Ltd., and has been approved in Japan under the brand name Xocova since 2022. In April 2023, the drug received “Fast Track” designation from the FDA, a status meant to expedite the agency’s review process.

When taken shortly after getting sick, ensitrelvir…


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