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Recall Alert

An update on the Cyclospora outbreak available here.

SKYSONA

STN: 125755
Proper Name: elivaldogene autotemcel
Tradename: SKYSONA 
Manufacturer: bluebird bio, Inc.

  • 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.

  • 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.

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