exagamglogene autotemcel

FDA Drug Profile — CASGEVY

Drug Details

Generic Name
exagamglogene autotemcel
Brand Names
CASGEVY
Application Number
BLA125787
Sponsor
Vertex Pharmaceuticals Incorporated
NDC Codes
1
Dosage Forms
INJECTION, SUSPENSION
Routes
INTRAVENOUS
Active Ingredients
EXAGAMGLOGENE AUTOTEMCEL

Indications and Usage

1. INDICATIONS AND USAGE CASGEVY is indicated for the treatment of patients aged 12 years and older with: sickle cell disease (SCD) with recurrent vaso-occlusive crises transfusion-dependent β - thalassemia (TDT) CASGEVY is an autologous genome edited hematopoietic stem cell-based gene therapy indicated for the treatment of patients aged 12 years and older with: sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs). ( 1 ) transfusion-dependent β-thalassemia (TDT). ( 1 )