Prophylaxis

• 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 FDA has approved the oral medication ensitrelvir for use as post-exposure prophylaxis (PEP) to prevent the onset of COVID-19 symptoms. • Approval follows phase 3 clinical trial data conducted between February 10 and July 10, 2022, across 92 sites in Japan, Vietnam, and South Korea, demonstrating efficacy against Omicron variants. • This development is significant as it provides a preventative option for individuals exposed to the virus in high-risk environments, including nursing homes, acute care facilities, and during travel.