STN: 125787
Proper Name: exagamglogene autotemcel (exa-cel)
Tradename: CASGEVY
Manufacturer: Vertex Pharmaceuticals Incorporated
Indication:
- STN 125787 – Treatment of sickle cell disease (SCD) and the treatment of transfusion dependent β-thalassemia (TDT) in patients 12 years of age and older.
- STN 125785 – Indicated for the treatment of patients aged 12 years and older with sickle cell disease (SCD) with recurrent vaso occlusive crises (VOCs) and transfusion-dependent ß-thalassemia (TDT).
Production Information
Supporting Documents
- March 18, 2026 Approval Letter – CASGEVY (125787)
- January 16, 2024 Approval Letter – CASGEVY (STN 125785)
- January 16, 2024 Summary Basis for Regulatory Action – CASGEVY (STN125785)
- December 8, 2023 Approval Letter – CASGEVY
- December 8, 2023 Summary Basis for Regulatory Action – CASGEVY
- Approval History, Letters, Reviews, and Related Documents – CASGEVY
- Approval History, Letters, Reviews, and Related Documents – CASGEVY (STN 125785)
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Content current as of:
03/25/2026



