Delandistrogene moxeparvovec
Elevidys (delandistrogene moxeparvovec) is a gene pharmaceutical. Delandistrogene moxeparvovec was first approved as Elevidys on 2023-06-22. It is used to treat duchenne muscular dystrophy in the USA.
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Elevidys
Drug Products
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EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Delandistrogene moxeparvovec
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| ELEVIDYS | delandistrogene moxeparvovec-rokl | Sarepta Therapeutics | N-125781 RX | 2023-06-22 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| elevidys | Biologic Licensing Application | 2024-09-06 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| duchenne muscular dystrophy | EFO_0000429 | D020388 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
delandistrogene moxeparvovec, ELEVIDYS, Sarepta Therapeutics, Inc. | |||
| 2035-06-22 | Reference product excl. | ||
| 2030-06-22 | Orphan excl. | ||
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Clinical
Clinical Trials
11 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Duchenne muscular dystrophy | D020388 | EFO_0000429 | — | 5 | 3 | 3 | — | 1 | 10 |
| Muscular dystrophies | D009136 | EFO_0000757 | G71.0 | 3 | 2 | 3 | — | — | 6 |
Indications Phases 2
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Delandistrogene moxeparvovec |
| INN | delandistrogene moxeparvovec |
| Description | Delandistrogene moxeparvovec, sold under the brand name Elevidys, is a recombinant gene therapy used for the treatment of Duchenne muscular dystrophy. It is designed to deliver into the body a gene that leads to production of Elevidys micro-dystrophin that contains selected domains of the dystrophin protein present in normal muscle cells. It is an adeno-associated virus vector-based gene therapy that is given by injection into a vein.
|
| Classification | Gene |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4650241 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16802 |
| UNII ID | 2P6QV2ZE52 (ChemIDplus, GSRS) |
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Elevidys – Sarepta Therapeutics
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Safety
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221 adverse events reported
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