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[Alpha Biz=(Chicago) Reporter Kim Jisun] Hugel's botulinum toxin 'Letybo' has been postponed again. The company plans to continue its challenge to enter the United States by reapplying within a year.
According to Hugel on the 18th, the company received a supplementary request letter (CRL) from the US Food and Drug Administration (FDA) for the Letybo Item License Application (BLA).
This is the second time Hugel has received an CRL related to Letybo. Hugel submitted BLA for Letybo 50 unit and 100 unit to FDA in March 2021. However, the entry into the United States was delayed as FDA demanded CRL in March of the following year. At that time, FDA was known to have asked for a supplement of permit-related materials and literature.
Hugel completed the reapplication in October of the same year after the request for supplementation, and attention has been paid to whether to grant permission or not this month. This is because the U.S. Act on the Cost of Prescription and Drug Application (PDUFA) guidelines provide a final decision on whether to approve the application within six months of receipt.
However, FDA is known to have requested additional updates on factory management that were not available at the time after the first due diligence.
Hugel will re-challenge the submission of the BLA according to the request for supplementation. The goal is to complete the resubmission within the next year and obtain permission within the next six months.
AlphaBIZ 김지선(stockmk2020@alphabiz.co.kr)
