Sangamo Therapeutics is anticipated to seek FDA approval for its Fabry gene therapy candidate, isaralgagene civaparvovec, in the second half of 2025. Here's the rationale behind this timeline:
- Data Availability: The complete dataset to support the Accelerated Approval pathway will be available in the first half of 2025.
- Submission Timeline: Sangamo expects to file the Biologics License Application (BLA) in the second half of 2025.
- FDA Review Process: The FDA's alignment on an accelerated approval pathway indicates a clear regulatory direction that typically precedes the submission of a BLA and the subsequent review process.
Given these points, it is reasonable to expect that Sangamo Therapeutics will pursue FDA approval for isaralgagene civaparvovec in the second half of 2025.
