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Home » Bluebird Bio cerebral adrenoleukodystrophy gene therapy on the brink of European approval as CHMP nods through eight applications
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Bluebird Bio cerebral adrenoleukodystrophy gene therapy on the brink of European approval as CHMP nods through eight applications

May 21, 2021
By Cormac Sheridan
DUBLIN – Skysona (elivaldogene autotemcel, Lenti-D), Bluebird Bio Inc.’s gene therapy for cerebral adrenoleukodystrophy, received a nod from the EMA’s Committee for Human Medicinal Products (CHMP) during its May meeting this week, paving the way for a formal European authorization in the coming weeks. It will constitute the first approval for the product. An FDA approval is some way behind – the company will not complete its BLA filing with the FDA until around midyear.
BioWorld Regulatory Gene therapy Europe CHMP

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