Last update 09 Dec 2024

Elivaldogene Autotemcel (Bluebird Bio)

Overview

Basic Info

Drug Type
Gene therapy, Stem cell therapy
Synonyms
Adrenoleucodystrophy gene therapy - bluebird bio, eli-cel, Elivaldogene autotemcel
+ [8]
Target
Mechanism
ABCD1 gene stimulants
Active Indication
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
EU (16 Jul 2021),
RegulationAccelerated Approval (US), Rare Pediatric Disease (US), Orphan Drug (EU), PRIME (EU), Breakthrough Therapy (US), Orphan Drug (US)
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Adrenoleukodystrophy
EU
16 Jul 2021
Adrenoleukodystrophy
IS
16 Jul 2021
Adrenoleukodystrophy
LI
16 Jul 2021
Adrenoleukodystrophy
NO
16 Jul 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
32
Elivaldogene autotemcel (eli-cel) gene therapy
aopufjsnbp(jmigjlwpeb) = qmvzncqiui iyqfcnlqvt (cnxldbkfkh )
Positive
10 Oct 2024
Phase 2/3
67
zuutrfzmxx(jflfrwcbma) = Few SAEs were reported during mobilization/apheresis; incidence was expectedly higher in conditioning and neutropenic periods, consistent with myeloablative transplant. No patients developed sinusoidal obstruction syndrome or new seizures; all survived to hospital discharge. As of Sep 6, 2023, 5 patients who received eli-cel were subsequently diagnosed with myelodysplastic syndrome. dgnnsowaak (uakczzagfx )
Positive
01 Feb 2024
Not Applicable
-
Elivaldogene Autotemcel (eli-cel; Lenti-D) Gene Therapy
mpmifzcffp(ahebxvrzul) = 2 events occurred in ALD-104 zhpztxgwig (fhegrcsurz )
Positive
01 Mar 2022
Phase 2/3
32
gsykavnpqb(sxjzulrdxa) = feewbeacte lzvijoxtap (jbmmuefwyg )
Positive
15 Mar 2021
Phase 2/3
21
uheqmptlox(amagtogdtt) = xjzeqvymzz amdvpoxics (reilpoipcp )
Positive
24 Sep 2018
Phase 2/3
17
ndrllljcnf(uazourumzv) = hleuwwgvxg zguitmpeez (gbbbxixkwv )
Positive
26 Oct 2017
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Regulation

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