Benzinga | Oct 21, 2021 12:12PM EDT

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.

* Related: Bluebird Bio's Shares Drop To 52-Week Low After Another Gene Therapy Trial Placed On FDA Hold.

* Price Action: BLUE shares are up 0.81% at $21.15 during the market session on the last check Thursday.