Skysona

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Withdrawn

This medicine's authorisation has been withdrawn

elivaldogene autotemcel
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 18 November 2021, the European Commission withdrew the marketing authorisation for Skysona (elivaldogene autotemcel) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, bluebird bio (Netherlands) B.V., which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Skysona was granted marketing authorisation in the EU on 16 July 2021 for treatment of early cerebral adrenoleukodystrophy. No patients had been treated with Skysona since its marketing authorisation. 

The European Public Assessment Report (EPAR) for Skysona is updated to indicate that the marketing authorisation is no longer valid.

Skysona : EPAR - Medicine overview

Reference Number: EMA/413176/2021

English (EN) (719.27 KB - PDF)

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български (BG) (809.77 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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español (ES) (717.73 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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čeština (CS) (788.7 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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dansk (DA) (714.49 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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Deutsch (DE) (722.06 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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eesti keel (ET) (709.45 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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ελληνικά (EL) (813.98 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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français (FR) (719.11 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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hrvatski (HR) (743.42 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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italiano (IT) (716.83 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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latviešu valoda (LV) (809.41 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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lietuvių kalba (LT) (748.43 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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magyar (HU) (789.47 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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Malti (MT) (802.26 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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Nederlands (NL) (716.27 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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polski (PL) (797.41 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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português (PT) (719.47 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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română (RO) (749.78 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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slovenčina (SK) (788.96 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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slovenščina (SL) (787.88 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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Suomi (FI) (714.38 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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svenska (SV) (716.09 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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Skysona : EPAR - Risk-management-plan summary

English (EN) (758.42 KB - PDF)

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Product information

Skysona : EPAR - Product information

English (EN) (1.45 MB - PDF)

First published: Last updated:
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български (BG) (2.6 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

español (ES) (1.42 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

čeština (CS) (2.36 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

dansk (DA) (1.39 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

Deutsch (DE) (1.59 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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eesti keel (ET) (1.36 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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ελληνικά (EL) (2.63 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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français (FR) (1.52 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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hrvatski (HR) (1.44 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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íslenska (IS) (1.41 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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italiano (IT) (1.52 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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latviešu valoda (LV) (2.3 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

lietuvių kalba (LT) (1.64 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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magyar (HU) (2.17 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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Malti (MT) (2.29 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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Nederlands (NL) (1.56 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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norsk (NO) (1.38 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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polski (PL) (2.35 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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português (PT) (1.41 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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română (RO) (1.54 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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slovenčina (SK) (2.22 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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slovenščina (SL) (2.19 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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Suomi (FI) (1.49 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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svenska (SV) (1.41 MB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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18/11/2021
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Skysona : EPAR - All authorised presentations

English (EN) (659.4 KB - PDF)

First published: Last updated:
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български (BG) (686.79 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

español (ES) (658.86 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

čeština (CS) (677.6 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

dansk (DA) (665.26 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

Deutsch (DE) (661.44 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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eesti keel (ET) (657.16 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
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ελληνικά (EL) (683.93 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

français (FR) (659.43 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

hrvatski (HR) (659.52 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

íslenska (IS) (660.93 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

italiano (IT) (657.56 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

latviešu valoda (LV) (677.33 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

lietuvių kalba (LT) (661.7 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

magyar (HU) (677.38 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

Malti (MT) (679.82 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

Nederlands (NL) (657.82 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

norsk (NO) (660.61 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

polski (PL) (678.57 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

português (PT) (659.12 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

română (RO) (660.43 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

slovenčina (SK) (677.66 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

slovenščina (SL) (675.2 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

Suomi (FI) (655.9 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

svenska (SV) (659.33 KB - PDF)

First published: 27/07/2021Last updated: 04/04/2022
View

Product details

Name of medicine
Skysona
Active substance
elivaldogene autotemcel
International non-proprietary name (INN) or common name
elivaldogene autotemcel
Therapeutic area (MeSH)
Adrenoleukodystrophy
Anatomical therapeutic chemical (ATC) code
N07

Pharmacotherapeutic group

Other nervous system drugs

Therapeutic indication

Treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an ABCD1 genetic mutation, and for whom a human leukocyte antigen (HLA) matched sibling haematopoietic stem cell donor is not available.

Authorisation details

EMA product number
EMEA/H/C/003690

Advanced therapy

This medicine is classified as an advanced therapy medicinal product (ATMP): a medicine for human use that is based on genes, tissues or cells. It offers groundbreaking new opportunities for the treatment of disease and injury. For more information, see Advanced therapy medicinal products: Overview.

PRIME: priority medicine

This medicine was granted entry to the EMA Priority Medicines (PRIME) scheme during its development. PRIME is a scheme launched by EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. For more information, see PRIME: priority medicines.

Marketing authorisation holder
bluebird bio (Netherlands) B.V.

Stadsplateau 7
3521 AZ Utrecht
The Netherlands

Opinion adopted
20/05/2021
Marketing authorisation issued
16/07/2021

Assessment history

Skysona : Orphan maintenance assessment report (initial authorisation)

AdoptedReference Number: EMADOC-1700519818-686727

English (EN) (889.37 KB - PDF)

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Skysona : EPAR - Public assessment report

AdoptedReference Number: EMA/332184/2021

English (EN) (6 MB - PDF)

First published: Last updated:
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CHMP summary of positive opinion for Skysona

AdoptedReference Number: EMA/CHMP/273940/2021

English (EN) (757.04 KB - PDF)

First published: Last updated:
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More information on Skysona

This product was originally designated an orphan medicine on 6 June 2012. Skysona was withdrawn from the Community register of orphan medicinal products by the European Commission in November 2021 at the time of the withdrawal of the marketing authorisation.

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