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Drug ReportsLanadelumab
Takhzyro(lanadelumab)
Takhzyro (lanadelumab) is an antibody pharmaceutical. Lanadelumab was first approved as Takhzyro on 2018-08-23. It has been approved in Europe to treat hereditary angioedemas. The pharmaceutical is active against plasma kallikrein.
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Clinical
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Target
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Financial
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Safety
Events Timeline
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3M
6M
YTD
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2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Takhzyro
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)
Lanadelumab
Tradename
Proper name
Company
Number
Date
Products
Takhzyrolanadelumab-flyoTakedaN-761090 RX2018-08-23
3 products
Labels
FDA
EMA
No data
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
lanadelumab, Takhzyro, Takeda Pharmaceuticals U.S.A., Inc.
2030-02-03Orphan excl.
Patent Expiration
No data
ATC Codes
B: Blood and blood forming organ drugs
B06: Other hematological agents in atc
B06A: Other hematological agents in atc
B06AC: Drugs used in hereditary angioedema
B06AC05: Lanadelumab
HCPCS
Code
Description
J0593
Injection, lanadelumab-flyo, 1 mg (code may be used for medicare when drug administered under direct supervision of a physician, not for use when drug is self-administered)
Clinical
Clinical Trials
29 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
Hereditary angioedemasD054179EFO_000413126614
AngioedemaD000799EFO_0005532T78.3224
Covid-19D000086382U07.11112
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hereditary autoinflammatory diseasesD05666011
HypotensionD007022EFO_0005251I9511
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients33
PneumoniaD011014EFO_000310611
Lung injuryD055370S27.3011
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLanadelumab
INNlanadelumab
Description
Lanadelumab, sold under the brand name Takhzyro, is a human monoclonal antibody (class IgG1 kappa) that targets plasma kallikrein (pKal) in order to promote prevention of angioedema in people with hereditary angioedema. Lanadelumab, was approved in the United States as the first monoclonal antibody indicated for prophylactic treatment to prevent hereditary angioedema attacks. Lanadelumab is the first treatment for hereditary angioedema prevention made by using cells within a lab, not human plasma.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID
RxCUI
ChEMBL IDCHEMBL3545189
ChEBI ID
PubChem CID
DrugBankDB14597
UNII ID2372V1TKXK (ChemIDplus, GSRS)
Target
Agency Approved
KLKB1
KLKB1
Organism
Homo sapiens
Gene name
KLKB1
Gene synonyms
KLK3
NCBI Gene ID
Protein name
plasma kallikrein
Protein synonyms
Fletcher factor, kallikrein B, plasma (Fletcher factor) 1, Kininogenin, PKK, Plasma prekallikrein
Uniprot ID
Mouse ortholog
Klkb1 (16621)
plasma kallikrein (Q8R0P5)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
£
Takhzyro Takeda
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 339 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,382 adverse events reported
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