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bluebird bio to withdraw marketing of Skysona gene therapy in Europe.
Bluebird Bio Inc will withdraw the regulatory marketing authorization for Skysona (elivaldogene autotemcel) in the European Union.
The update comes as a part of the company's winding down of operations there. Bluebird will also withdraw marketing authorization of the biologic in the UK. Skysona (elivaldogene autotemcel, Lenti-D), one-time gene therapy, is indicated for early cerebral adrenoleukodystrophy (CALD) in patients under 18 years of age with an ABCD1 genetic mutation.
In addition, the company will withdraw authorizations for Zynteglo (betibeglogene autotemcel) in the EU and UK in early 2022. The company does not intend to initiate any new trials in Europe for beta-thalassemia, cerebral adrenoleukodystrophy, or sickle cell disease programs.
Condition: Cerebral Adrenoleukodystrophy
Type: drug