First Pill to Prevent COVID-19 After Exposure Approved by FDA
The five-day regimen cut symptomatic COVID-19 risk by 67% in trials, according to Shionogi.
- The FDA approved XOCOVA on Monday, the first oral medication for COVID-19 post-exposure prophylaxis, according to manufacturer Shionogi. The five-day pill regimen is approved for people aged 12 and older.
- According to Shionogi, the oral antiviral works by blocking viral replication before symptoms develop. Patients take three tablets on the first day, followed by one tablet daily for the next four days.
- In the phase 3 SCORPIO-PEP trial, Ensitrelvir reduced the risk of developing symptomatic COVID-19 by 67% compared to placebo. Treatment participants showed 2.9% infection rates versus 9% in the placebo group.
- This approval arrives during a precarious time for COVID-19 prevention amid federal scrutiny of vaccines. As of May 9, only 18% of adults in the United States had received an updated vaccine for the 2025-2026 season, according to the CDC.
- Ensitrelvir was already approved for COVID-19 PEP in Japan, where the medication has been allowed as a treatment since 2022. However, it is not approved for that specific indication in the United States.
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FDA approves Xocova for COVID-19 prevention after exposure
The FDA on Monday approved the first medication for COVID-19 prevention that people can take after they have been exposed to someone with the disease, according to the drug’s manufacturer, Shionogi.Xocova (ensitrelvir) was approved as COVID-19 post-exposure prophylaxis for patients aged 12 years or older, the drug maker announced.
FDA Approves Oral Ensitrelvir for COVID-19 Post-Exposure Prophylaxis
FDA Approves Oral Ensitrelvir for COVID-19 Post-Exposure Prophylaxis AJMC Article Attribution | Read More at Article Source The post FDA Approves Oral Ensitrelvir for COVID-19 Post-Exposure Prophylaxis – AJMC appeared first on RocketNews.
FDA Approves Pill for COVID-19 Prevention
The Food and Drug Administration has approved a new drug for people to take after they are exposed to COVID-19. The FDA approved Xocova, a pill also known as ensitrelvir, on May 29, according to the FDA website. The approval is for post-exposure prophylaxis following COVID-19 exposure. Labeling and other information have not yet been released. Shionogi, the Japan-based company that makes Xovoca, said in a June 1 statement that the approval is fo…
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