SKYSONA
STN: 125755
Proper Name: elivaldogene autotemcel
Tradename: SKYSONA
Manufacturer: bluebird bio, Inc.
Indication:
- SKYSONA is indicated to slow the progression of neurologic dysfunction in boys 4- 17 years of age with early, active cerebral adrenoleukodystrophy (CALD) without an available human leukocyte antigen (HLA)-matched donor for allogeneic hematopoietic stem cell transplant.
Latest Safety Information
Product Information
- Package Insert - SKYSONA
- Demographic Subgroup Information – elivaldogene autotemcel [SKYSONA]
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.