FDA accepts Shionogi’s ensitrelvir (Xocova) NDA for review as the first oral therapy for the prevention of COVID-19 following exposure

Shionogi & Co., Ltd. announced the FDA has accepted for review a New Drug Application (NDA) from Shionogi Inc., its US subsidiary for ensitrelvir (Xocova, enensitrelvir fumaric acid, S 217622), an investigational oral antiviral for the prevention of Covid-19 following exposure to an infected individual. The FDA has set an action date of June 16, 2026 under the Prescription Drug User Fee Act (PDUFA). The NDA is supported by results from the global, double-blind, randomized, placebo-controlled Phase III study, SCORPIO-PEP, which studied ensitrelvir as post-exposure prophylaxis (PEP). If approved, ensitrelvir would be the first and only oral therapy for the prevention of COVID-19 following exposure to an infected individual.

“Shionogi has a long history of innovation in infectious disease treatment and prevention. Our dedication to this field has led to significant breakthroughs in the development of novel antimicrobials and antivirals for HIV/AIDS, influenza and COVID-19. If approved, ensitrelvir will be the first and only oral therapy to help protect people in the U.S. from COVID-19 following exposure,” said Nathan McCutcheon, President and CEO, Shionogi Inc.