Ildong Pharmaceutical to refile approval application for oral Covid-19 treatment
Ildong Pharmaceutical announced plans to reapply for marketing authorization of the oral antiviral Covid-19 treatment, Ensitrelvir fumaric acid, after strengthening its clinical data.
The company aims to incorporate findings from the recently completed global clinical trial, SCORPIO-PEP, which evaluated the drug’s effectiveness in post-exposure prophylaxis (PEP).
According to Ildong, SCORPIO-PEP, conducted by the Japanese pharmaceutical company Shionogi, is expected to provide valuable data demonstrating Ensitrelvir’s preventive benefits when used in individuals exposed to Covid-19-positive cases. Ildong plans to combine these results with existing clinical data to enhance the overall efficacy profile of the drug and reapply for regulatory approval in Korea.
Ildong has also voluntarily withdrawn its initial marketing application filed with the Ministry of Food and Drug Safety (MFDS) on Thursday. The company had previously submitted the treatment for approval to the MFDS in December of last year.
The company noted that the analysis and compilation of SCORPIO-PEP data would likely be finalized after the timeline of the original application process, necessitating the withdrawal.
Ildong’s initial application included data from two key studies, SCORPIO-SR and SCORPIO-HR, which demonstrated the therapeutic efficacy of Ensitrelvir in symptomatic Covid-19 patients.
SCORPIO-SR focused on individuals with mild to moderate symptoms, while SCORPIO-HR targeted high-risk patients. However, the company believes that integrating SCORPIO-PEP’s findings with these existing datasets will more effectively highlight the drug’s comprehensive potential in treating and preventing Covid-19.
“Combining the positive outcomes of SCORPIO-PEP with data from SCORPIO-SR and SCORPIO-HR will showcase Ensitrelvir’s overall value and enhance its positioning for regulatory approval,” an Ildong official said.
Ildong plans to proceed with the local approval process as soon as the SCORPIO-PEP data analysis is completed, he added.