Bluebird Bio To Withdraw Marketing Of Skysona Gene Therapy In Europe

·1 min read
  • 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.

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