FDA Approves Xocova, First Oral COVID-19 Prevention Pill Reducing Risk by 67%
FDA approves pill that cuts COVID risk nearly 70%
New Atlas
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The FDA has approved Xocova (ensitrelvir), the first oral COVID-19 post-exposure prophylaxis, which reduces the risk of symptomatic infection by 67% after exposure. Developed by Shionogi, it offers a new preventive option for adults and adolescents aged 12 and older.
- 01Xocova, developed by Shionogi, is the first oral COVID-19 prevention pill approved by the FDA.
- 02In a Phase III trial, Xocova reduced the risk of symptomatic COVID-19 by 67% after exposure.
- 03The treatment consists of a five-day regimen, starting with three pills on the first day followed by one pill daily.
- 04Side effects were minimal, with serious adverse events occurring in only 0.2% of participants.
- 05Xocova is approved for use in individuals aged 12 years and older, regardless of vaccination status.
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The U.S. Food and Drug Administration (FDA) has approved Xocova (ensitrelvir), marking the first oral post-exposure prophylaxis for COVID-19. Developed by the Japanese pharmaceutical company Shionogi, Xocova is designed to reduce the risk of contracting COVID-19 after exposure, cutting symptomatic infection risk by 67% according to a Phase III trial. The treatment involves a five-day regimen: three tablets taken on the first day, followed by one tablet each subsequent day. The trial included over 2,000 participants, with side effects reported at low rates (15.1% for the treatment group), and no hospitalizations due to COVID-19 were required. Frederick Hayden, MD, emphasized the significance of this new preventive approach, particularly for vulnerable settings like nursing homes. Nathan McCutcheon, CEO of Shionogi Inc., highlighted that Xocova is clinically proven to help prevent symptomatic COVID-19 regardless of prior immunity or vaccination status. The drug will be available for adults and adolescents aged 12 and older.
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Xocova offers a new preventive option for individuals exposed to COVID-19, potentially reducing transmission rates.
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