Shots:
- The US FDA has approved Xocova (ensitrelvir) for post-exposure prophylaxis (PEP) of COVID-19 in adults and adolescents (age≥12 yrs) following exposure to a person with COVID-19
- Approval was based on a global P-III (SCORPIO-PEP) trial in 2,387 participants aged ≥12 yrs exposed to a household member with symptomatic COVID-19. The primary analysis included 2,041 SARS-CoV-2-negative participants who received Xocova (n=1,030; 375 mg on day 1 & 125 mg on days 2-5) or PBO (n=1,011) within 72 hours of symptom onset in the index case
- The trial demonstrated a 67% reduction in the risk of symptomatic COVID-19 through Day 10 vs PBO, met its 1EP in PEP. Xocova was generally well tolerated, with comparable adverse event rates between the treatment (15.1%) and PBO (15.5%), results were published in the NEJM on May 14, 2026
Ref: Shionogi | Image: Shionogi | Press Release
Related News: Pfizer Signs ~$530M Deal to Use Novavax’s Adjuvant in Product Development
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
