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Formed in 2009, the Archive Team (not to be confused with the archive.org Archive-It Team) is a rogue archivist collective dedicated to saving copies of rapidly dying or deleted websites for the sake of history and digital heritage. The group is 100% composed of volunteers and interested parties, and has expanded into a large amount of related projects for saving online and digital history.

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Review
.2021 Nov;25(6):803-809.
doi: 10.1007/s40291-021-00555-1. Epub 2021 Aug 23.

Elivaldogene Autotemcel: First Approval

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Review

Elivaldogene Autotemcel: First Approval

Susan J Keam. Mol Diagn Ther.2021 Nov.

Abstract

Elivaldogene autotemcel (SKYSONA™, eli-cel; Lenti-D™ gene therapy) is a gene therapy that has been developed by bluebird bio for the treatment of cerebral adrenoleukodystrophy (CALD), a rare, X-linked genetic disease that mainly affects the nervous system and adrenal glands. In July 2021, elivaldogene autotemcel received its first approval (in the EU) for the treatment of for the treatment of early CALD in patients < 18 years of age, with an ABCD1 genetic mutation, and for whom a human leukocyte antigen (HLA)-matched sibling haematopoietic stem cell (HSC) donor is not available. This article summarizes the milestones in the development of elivaldogene autotemcel leading to this first approval.

© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.

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References

    1. bluebird bio. Our science: what is gene therapy? 2021.https://www.bluebirdbio.com/our-science/what-is-gene-therapy . Accessed 19 July 2021.
    1. European Medicines Agency. Skysona (elivaldogene autotemcel): EU summary of product characteristics. 2021.https://www.ema.europa.eu/ . Accessed 26 July 2021.
    1. bluebird bio. Fom 10-K. 2021.https://investor.bluebirdbio.com/static-files/a0cfdff2-2784-4e01-9237-8b... . Accessed 7 July 2021.
    1. Federico A, de Visser M. New disease modifying therapies for two genetic childhood-onset neurometabolic disorders (metachromatic leucodystrophy and adrenoleucodystrophy). Neurol Sci. 2021;42(7):2603–6. - DOI
    1. Musolino P, Lauer A, Choi M, et al. Lenti-D gene therapy attenuates microvascular perfusion abnormalities and halts cerebral adrenoleukodystrophy lesion progression [abstract no. 156]. Ann Neurol. 2019;86(Suppl 23):S113–4.

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