Post Exposure

• The FDA has approved the first generic version of baloxavir tablets for the treatment and postexposure prophylaxis of influenza. • The medication is indicated for patients aged 5 years or older, including those who have been exposed to an individual with the flu. • This approval is based on the generic product meeting regulatory standards for equivalence to the reference listed drug rather than new clinical efficacy data.

• The FDA has approved the oral antiviral ensitrelvir (Xocova), developed by Shionogi & Co, Ltd, for post-exposure prophylaxis (PEP) of COVID-19. • The treatment is authorized for use in adults and adolescents aged 12 years and older to prevent symptomatic SARS-CoV-2 infection. • Approval was based on the SCORPIO-PEP phase 3 trial, which demonstrated the drug's safety and efficacy in household contacts of symptomatic patients.

• The U.S. FDA has approved ensitrelvir (Xocova), an oral antiviral developed by Shionogi, for the post-exposure prevention of COVID-19. • The medication is authorized for use in individuals aged 12 years and older who have been exposed to the SARS-CoV-2 virus. • This approval is significant as Xocova becomes the first and only oral medication specifically authorized to reduce the risk of infection after a known exposure.