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
Clinical :: Oncology :: Nuclear :: Geriatric :: Regulatory :: Technology :: Consulting
"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.
Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.
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