NEWS
Sangamo Therapeutics Announces Alignment With FDA on Accelerated Approval Pathway for ST-920 in Fabry Disease With BLA Submission Expected in 2025
U.S. Food and Drug Administration (FDA) provides a clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec using data from ongoing Phase 1/2 STAAR study, avoiding requirement for additional registrational study and accelerating estimated time to potential approval by approximately three years.
- FDA confirms that estimated glomerular filtration rate (eGFR) slope data at one year across all Phase 1/2 patients can serve as primary basis for approval under Accelerated Approval pathway.
- Data to support Accelerated Approval pathway available in first half of 2025, with a potential Biologics License Application (BLA) submission expected in the second half of 2025.
- FDA confirms that estimated glomerular filtration rate (eGFR) slope data at one year across all Phase 1/2 patients can serve as primary basis for approval under Accelerated Approval pathway.
- Data to support Accelerated Approval pathway available in first half of 2025, with a potential Biologics License Application (BLA) submission expected in the second half of 2025.
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