SKYSONA
STN: 125755
Proper Name: elivaldogene autotemcel
Tradename: SKYSONA
Manufacturer: bluebird bio, Inc.
Indication:
- To slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD).
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.
Supporting Documents
- September 16, 2022 Approval Letter - SKYSONA
- Summary Basis for Regulatory Action - SKYSONA
- Approval History, Letters, Reviews and Related Documents - SKYSONA