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Reblozyl(luspatercept)
Reblozyl (luspatercept) is a protein pharmaceutical. Luspatercept was first approved as Reblozyl on 2019-11-08. It is used to treat anemia in the USA. It has been approved in Europe to treat anemia, beta-thalassemia, and myelodysplastic syndromes. It is known to target growth/differentiation factor 11, bone morphogenetic protein 10, growth/differentiation factor 2, growth/differentiation factor 8, and bone morphogenetic protein 6.
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BMS
FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
Reblozyl
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)
Luspatercept
Tradename
Proper name
Company
Number
Date
Products
Reblozylluspatercept-aamtCelgeneN-761136 RX2019-11-08
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
reblozylBiologic Licensing Application2020-10-16
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
anemiaEFO_0004272D000740D64.9
Agency Specific
FDA
EMA
Expiration
Code
luspatercept, Reblozyl, Celgene Corporation, a Bristol-Myers Squibb Company
2027-04-03Orphan excl.
Patent Expiration
No data
ATC Codes
B: Blood and blood forming organ drugs
— B03: Antianemic preparations
— B03X: Other antianemic preparations in atc
— B03XA: Other antianemic preparations in atc
— B03XA06: Luspatercept
HCPCS
Code
Description
J0896
Injection, luspatercept-aamt, 0.25 mg
Clinical
Clinical Trials
27 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Beta-thalassemiaD017086Orphanet_848D56.1—321—6
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190D46264——10
AnemiaD000740EFO_0004272D64.9141——6
Primary myelofibrosisD055728D47.4—11——2
Erythrocyte transfusionD017707——1——1
Myeloproliferative disordersD009196D47.1——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ThalassemiaD013789EFO_1001996D56—1———1
Alpha-thalassemiaD017085Orphanet_846D56.0—1———1
ThrombocytosisD013922D75.83—1———1
Aplastic anemiaD000741HP_0001915D61.9—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 nameLUSPATERCEPT
INNluspatercept
Description
Luspatercept
Classification
Protein
Drug classreceptor molecules or membrane ligands, natural, modified or modified: transforming growth factor receptors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1373715-00-4
RxCUI2262544
ChEMBL IDCHEMBL3039545
ChEBI ID—
PubChem CID—
DrugBankDB12281
UNII IDAQK7UBA1LS (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
GDF11
GDF11
BMP10
BMP10
GDF2
GDF2
MSTN
MSTN
BMP6
BMP6
Organism
Homo sapiens
Gene name
GDF11
Gene synonyms
BMP11
NCBI Gene ID
10220
Protein name
growth/differentiation factor 11
Protein synonyms
BMP-11, Bone morphogenetic protein 11, GDF-11
Uniprot ID
Q9UID2
Mouse ortholog
Gdf11 (14561)
growth/differentiation factor 11 (Q9Z1W4)
Variants
Clinical Variant
No data
Financial
Reblozyl - Bristol Myers Squibb
$
€
£
₣
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Reblozyl - Merck Sharp & Dohme
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 473 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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171 adverse events reported
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