Approves Oral

• The FDA has approved Shionogi’s Xocova (ensitrelvir) as the first oral therapy designed to prevent Covid-19 after a person has been exposed to the virus. • The approval follows the Scorpio-Pep trial involving 2,387 participants aged 12 and older who were asymptomatic but had been exposed to a symptomatic household member. • The drug works by inhibiting viral replication, offering a critical new preventative tool for those who initiate treatment within 72 hours of their contact's symptom onset.

• 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.

• 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.

• The FDA has approved ensitrelvir, an oral antiviral medication specifically designed to prevent COVID-19 after a person has been exposed to the virus. • Approval follows the phase III SCORPIO-PEP trial, which demonstrated that the drug reduced the risk of developing COVID-19 by more than half for individuals who were household contacts of an infected person. • This marks a significant shift in prevention strategy, though the medication is currently not approved for treating active COVID-19 infections within the U.S.