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Evenity(romosozumab)
Evenity (romosozumab) is an antibody pharmaceutical. Romosozumab was first approved as Evenity on 2019-04-09. It is used to treat postmenopausal osteoporosis in the USA. It has been approved in Europe to treat osteoporosis. The pharmaceutical is active against sclerostin.
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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Evenity
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)
Romosozumab
Tradename
Proper name
Company
Number
Date
Products
Evenityromosozumab-aqqgAmgenN-761062 RX2019-04-09
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
evenityBiologic Licensing Application2020-04-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
postmenopausal osteoporosisEFO_0003854D015663—
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
M: Musculo-skeletal system drugs
— M05: Drugs for treatment of bone diseases
— M05B: Drugs affecting bone structure and mineralization
— M05BX: Other drugs affecting bone structure and mineralization in atc
— M05BX06: Romosozumab
HCPCS
Code
Description
J3111
Injection, romosozumab-aqqg, 1 mg
Clinical
Clinical Trials
28 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Postmenopausal osteoporosisD015663EFO_0003854—242—8
OsteoporosisD010024EFO_0003882M81.02132—8
Spinal cord injuriesD013119EFO_1001919—1—2—3
Osteoporotic fracturesD058866———2—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Metabolic bone diseasesD001851HP_0000938411——6
Feeding and eating disordersD001068F50——1——1
Anorexia nervosaD000856EFO_0004215F50.0——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Fracture healingD017102—2———2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Osteogenesis imperfectaD010013Q78.01————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameROMOSOZUMAB
INNromosozumab
Description
Romosozumab (humanized mab)
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID909395-70-6
RxCUI—
ChEMBL IDCHEMBL2107874
ChEBI ID—
PubChem CID—
DrugBankDB11866
UNII ID3VHF2ZD92J (ChemIDplus, GSRS)
Target
Agency Approved
SOST
SOST
Organism
Homo sapiens
Gene name
SOST
Gene synonyms
NCBI Gene ID
50964
Protein name
sclerostin
Protein synonyms
Uniprot ID
Q9BQB4
Mouse ortholog
Sost (74499)
sclerostin (Q9D3L7)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Evenity - Amgen
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,485 documents
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Safety
Black-box Warning
Black-box warning for: Evenity
Adverse Events
Top Adverse Reactions
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17,318 adverse events reported
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