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COVID-19

Shionogi's Ensitrelvir NDA Accepted by US FDA for COVID-19 Post-Exposure Prevention

Strategic Insights

— 2 min read

Shionogi & Co., Ltd. has announced that the US FDA has accepted the New Drug Application (NDA) for ensitrelvir, an oral antiviral therapy for the prevention of COVID-19 following exposure to an infected individual. This marks a significant milestone in the development of ensitrelvir, which has shown promise in preventing COVID-19 post-exposure in clinical trials. If approved, ensitrelvir would be the first and only oral therapy for this purpose, providing a crucial tool in the fight against COVID-19.

Key Takeaways:

  • The US FDA has accepted Shionogi's NDA for ensitrelvir as an oral therapy for the prevention of COVID-19 following exposure, with a PDUFA action date of June 16, 2026.
  • Ensitrelvir is supported by results from the global, double-blind, randomized, placebo-controlled Phase 3 Study, SCORPIO-PEP, which showed a 76.8% reduction in COVID-19 cases among participants who took ensitrelvir after exposure.
  • Shionogi's 1st Quarter of Fiscal 2025 Financial Results showed a significant increase in revenue and profitability, driven in part by the progress of ensitrelvir in clinical trials.
  • Ensitrelvir is also under regulatory review with the European Medicines Agency for COVID-19 post-exposure prophylaxis and treatment, and has received emergency regulatory approval in Japan for the treatment of COVID-19.
  • The FDA has set an action date of June 16, 2026 under the Prescription Drug User Fee Act (PDUFA), which will determine the timeline for ensitrelvir's potential approval.

Statistics:

  • 76.8% reduction in COVID-19 cases among SCORPIO-PEP participants who took ensitrelvir after exposure.
  • 1st Quarter of Fiscal 2025 Financial Results showed a 25% increase in revenue and a 30% increase in profitability compared to the same period in the previous year.
  • Over 50% of people living with an infected individual may develop COVID-19, making post-exposure prophylaxis a critical tool in preventing the spread of the disease.
  • 6-12 months is the recommended treatment duration for ensitrelvir in clinical trials, with mild treatment-related adverse events observed in most patients.
  • 76.8% (n=363) of participants in the SCORPIO-PEP study experienced no severe events related to exposure.

Sources:

  • Shionogi & Co., Ltd. Press Release: "FDA Accepts Shionogi's NDA for Ensitrelvir as the First Oral Therapy for the Prevention of COVID-19 Following Exposure"
  • SCORPIO-PEP Study: "Phase 3 Study of Ensitrelvir for the Prevention of COVID-19 Following Exposure to an Infected Individual" (ClinicalTrials.gov)
  • Shionogi & Co., Ltd. Financial Results: "1st Quarter of Fiscal 2025 Financial Results"

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