Ildong Pharmaceutical announced plans to resubmit its application for product approval of Ensitrelvir fumaric acid, an oral antiviral drug being developed as a COVID-19 treatment. This decision follows the completion of Shionogi's global clinical trial, SCORPIO-PEP, which assessed Ensitrelvir's effectiveness as a post-exposure prophylactic.
The company intends to incorporate the SCORPIO-PEP trial data into its updated application, aiming to provide a more comprehensive demonstration of Ensitrelvir’s efficacy and value. This strategic move aligns with Shionogi's broader global regulatory strategy, which includes seeking approvals from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
To facilitate the integration of the new data, Ildong Pharmaceutical has voluntarily withdrawn its existing product license application submitted to the Ministry of Food and Drug Safety. The initial application was based on the SCORPIO-SR and SCORPIO-HR clinical trials, which focused on the therapeutic effects of Ensitrelvir in symptomatic COVID-19 patients. The SCORPIO-PEP trial, in contrast, evaluated the drug's preventive efficacy in individuals exposed to the virus.
An official from Ildong Pharmaceutical stated, "We plan to resume the domestic product approval process for Ensitrelvir when the analysis and collection of SCORPIO-PEP clinical research data is completed."
The company considered the timeline for completing the analysis of the SCORPIO-PEP data relative to the existing approval process. By expanding the application to include the post-exposure prophylaxis data, Ildong aims to present a more robust case for Ensitrelvir's overall utility in combating COVID-19.
