Application is based on results from SCORPIO-PEP, the first and only Phase 3 study of an oral antiviral to meet the primary endpoint of preventing COVID-19 following exposure to an infected individual
Shionogi & Co., Ltd. announced the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) from Shionogi Inc., a New Jersey-based subsidiary of Shionogi, for ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: 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).
Health Technology Insights: New Digestive Breath Device Shows Key Gut Health Benefits
The NDA is supported by results from the global, double-blind, randomized, placebo-controlled Phase 3 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.
SARS-CoV-2 remains highly transmissible and up to half of people living with an infected individual may develop COVID-19. The virus is constantly evolving, with novel symptoms reported. COVID-19 continues to impact daily life and may lead to absence from school and work, may cause long COVID, and in some cases, may progress to severe disease. Even patients with mild COVID-19 may experience worsening of preexisting chronic conditions.
Health Technology Insights: Novotech Backs Approval of Anlotinib Combination for Soft Tissue Sarcoma
Following exposure to COVID-19, the best way to avoid its potentially serious and long-term complications is to stop viral replication, which prevents the development of the disease. There are currently no approved antiviral therapies proven to prevent COVID-19 following exposure. COVID-19 vaccines are received before exposure, and they do not stop viral replication. Other COVID-19 antivirals are taken following exposure and diagnosis, after viral replication has occurred and disease is already established.
“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, MBA, President and CEO, Shionogi Inc.
Health Technology Insights: Zydus Reports Positive Phase 2/3 Results for Saroglitazar Trial
To participate in our interviews, please write to our HealthTech Media Room at sudipto@intentamplify.com
