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Elapegademase
Revcovi (elapegademase) is an enzyme pharmaceutical. Elapegademase was first approved as Revcovi on 2018-10-05.
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Revcovi
Drug Products
FDA
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)
Elapegademase
Tradename
Proper name
Company
Number
Date
Products
Revcovielapegademase-lvlrChiesi USA, Inc.N-761092 RX2018-10-05
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
revcoviBiologic Licensing Application2022-08-31
revcoviBiologic Licensing Application2022-08-31
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
elapegademase, Revcovi, Chiesi USA, Inc.
2025-10-05Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L03: Immunostimulants
— L03A: Immunostimulants
— L03AX: Other immunostimulants in atc
— L03AX21: Elapegademase
HCPCS
No data
Clinical
Clinical Trials
30 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeiomyomaD007889HP_0000131D25—24118
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EndometriosisD004715EFO_0001065N80179—118
MenorrhagiaD008595N92.0——4—15
InfertilityD007246EFO_0000545111——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Polycystic ovary syndromeD011085EFO_0000660E28.2—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameELAPEGADEMASE
INNelapegademase
Description
Elapegademase, sold under the brand name Revcovi, is a medication for the treatment of the rare disease adenosine deaminase deficiency-SCID in children and adults.
Classification
Enzyme
Drug classenzymes; PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL3990026
ChEBI ID—
PubChem CID—
DrugBankDB14712
UNII ID9R3D3Y0UHS (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 25 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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2,779 adverse events reported
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