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Kepivance(palifermin)
Kepivance (palifermin) is a protein pharmaceutical. Palifermin was first approved as Kepivance on 2004-12-15. It is used to treat mucositis in the USA. It has been approved in Europe to treat mucositis. The pharmaceutical is active against fibroblast growth factor receptor 2.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
stomatognathic diseasesD009057
Trade Name
FDA
EMA
Kepivance
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)
Palifermin
Tradename
Proper name
Company
Number
Date
Products
KepivancepaliferminSwedish Orphan Biovitrum AB (publ)N-125103 RX2004-12-15
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
kepivanceBiologic Licensing Application2020-04-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mucositisEFO_1001898D052016—
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AF: Detoxifying agents for antineoplastic treatment
— V03AF08: Palifermin
HCPCS
Code
Description
J2425
Injection, palifermin, 50 micrograms
Clinical
Clinical Trials
3 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ImpetigoD007169EFO_1000714L01——2——2
Indications Phases 2
No data
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 namePALIFERMIN
INNpalifermin
Description
Palifermin (trade name Kepivance, marketed by Biovitrum) is a truncated human recombinant keratinocyte growth factor (KGF) produced in Escherichia coli. KGF stimulates the growth of cells that line the surface of the mouth and intestinal tract.
Classification
Protein
Drug classgrowth factors: fibroblast growth factors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID162394-19-6
RxCUI196319
ChEMBL IDCHEMBL1201821
ChEBI ID—
PubChem CID—
DrugBankDB00039
UNII IDQMS40680K6 (ChemIDplus, GSRS)
Target
Agency Approved
FGFR2
FGFR2
Organism
Homo sapiens
Gene name
FGFR2
Gene synonyms
BEK, KGFR, KSAM
NCBI Gene ID
2263
Protein name
fibroblast growth factor receptor 2
Protein synonyms
bacteria-expressed kinase, BEK fibroblast growth factor receptor, CD332, K-sam, Keratinocyte growth factor receptor, KGFR, protein tyrosine kinase, receptor like 14
Uniprot ID
Q9UQI0
Mouse ortholog
Fgfr2 (14183)
fibroblast growth factor receptor 2 (P21803)
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 713 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,473 adverse events reported
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