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FDA Approves Bluebird Bio’s $3 Million CALD Treatment

September 21, 2022


FDA granted accelerated approval to Skysona (elivaldogene autotemcel), which is designed to slow the progression of neurologic dysfunction in adolescents with CALD.

FDA announced that it had granted approval of SKYSONA (elivaldogene automecel) to bluebird bio for the treatment of active cerebral adrenoleukodystrophy (CALD) on Sept. 16, 2022. The treatment, a one-time infusion, is set to have a wholesale acquisition cost of three million dollars, making it one of the most expensive treatments on the market.

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