Elivaldogene autotemcel is indicated for the treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an ABCD1 genetic mutation. Elivaldogene autotemcel adds functional copies of the ABCD1 cDNA into patients' HSCs through transduction of autologous CD34+ cells with Lenti-D LVV. Following successful engraftment with genetically modified cells, the expression of ALDP is expected to be life-long.
This medicinal substance has been classified in the anatomical therapeutic chemical (ATC) classification according to its main therapeutic use as follows:
| ATC code | Group title | Classification |
|---|---|---|
| A16AX21 | A Alimentary tract and metabolism → A16 Other alimentary tract and metabolism products → A16A Other alimentary tract and metabolism products → A16AX Various alimentary tract and metabolism products | |
Competent medicine agencies globally have authorized commercialization of this active ingredient according to these medication package inserts (MPIs):
| Title | Information Source | Document Type | |
|---|---|---|---|
| SKYSONA Dispersion for infusion | European Medicines Agency (EU) | MPI, EU: SmPC |
Elivaldogene autotemcel is an active ingredient of these brands:
Estonia (EE)France (FR)Lithuania (LT)Poland (PL)Note the following: The list of brand names is continuously updated, and thus does not include the total of products circulating worldwide. |
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