Bluebird Bio To Withdraw Marketing Of Skysona Gene Therapy In Europe

 

• Bluebird Bio Inc (NASDAQ: BLUE) 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.

• Adrenoleukodystrophy (ALD) is a disease linked to the X chromosome due to fatty acid buildup caused by a defect in the very long chain of fatty acids transporter in peroxisomes, resulting in damage to the myelin sheath of the nerves, hence seizures and hyperactivity.

• 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.

https://finance.yahoo.com/news/bluebird-bio-withdraw-marketing-skysona-135957524.html