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In this section: Vaccines, Blood & Biologics

CASGEVY

STN: 125787
Proper Name: exagamglogene autotemcel (exa-cel)
Tradename: CASGEVY
Manufacturer: Vertex Pharmaceuticals Incorporated

Indication:

STN 125787 - Treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso occlusive crises (VOCs).
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

Package Insert - CASGEVY (STN 125787)
Package Insert - CASGEVY (STN125785)
Demographic Subgroup Information- exagamglogene autotemcel (exa-cel) [CASGEVY]
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.

Supporting Documents

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