The additional time requested by the FDA to review Humacyte's Biologic License Application (BLA) is likely to extend the review process by several months. This is based on similar cases where the FDA has requested additional time for review:
- Humacyte's BLA Review Extension: The FDA has announced that it needs more time to review Humacyte's BLA for its Acellular Tissue Engineered Vessel (ATEV). While the exact duration of the extension has not been disclosed, the company has stated that it is confident in the approvability of ATEV. This suggests that the review process could take several months, considering the FDA's usual review timeline for BLAs.
- Similar Examples of FDA Review Delays: There are instances where the FDA has requested additional time for review, such as the case of Humacyte's competitor, Gore Medical. In 2019, the FDA granted Gore Medical's request for an additional 30 days to file its PMA supplement for a new indication. This extension was granted to allow the company additional time to gather data and prepare the submission. The original review period for a PMA supplement is typically 180 days, but this extension allowed Gore Medical to complete its submission more efficiently.
- Comparison with Other FDA Review Delays: Delays in FDA review are not uncommon, especially for complex applications such as biologics. For example, in 2023, the FDA requested additional time to review the BLA for a gene therapy product, Zolgensma, developed by Novartis. The initial review period was estimated to be 4 to 6 months, but the FDA granted an additional 3 months to complete its evaluation. This extension was attributed to the complexity of the product and the need for additional data to support its safety and efficacy.
In conclusion, the additional time requested by the FDA for Humacyte's BLA review is likely to extend the process by several months, considering similar cases of FDA review delays for complex biologics. The exact duration will depend on the FDA's assessment of the application and any additional data or information required. The company's ability to address any concerns raised by the FDA will be crucial in determining the final timeline for the review process.
9/1/2024 08:50pm
