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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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COVID-19
Top 200 Pharmaceuticals by Retail Sales
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
Brand Name
Status
Last Update
takhzyroBiologic Licensing Application2019-12-05
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
21 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_00041312—6—210
Covid-19D000086382U07.1111——2
AngioedemaD000799EFO_0005532T78.3——2——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hereditary autoinflammatory diseasesD056660—1———1
HypotensionD007022EFO_0005251I95—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—3————3
PneumoniaD011014EFO_0003106J181————1
Lung injuryD055370S27.301————1
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 (HAE) attacks. Lanadelumab is the first treatment for hereditary angioedema (HEA) prevention made by using cells within a lab, not human plasma.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1426055-14-2
RxCUI2055641
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
3818
Protein name
plasma kallikrein
Protein synonyms
Fletcher factor, kallikrein B, plasma (Fletcher factor) 1, Kininogenin, PKK, Plasma prekallikrein
Uniprot ID
P03952
Mouse ortholog
Klkb1 (16621)
plasma kallikrein (Q8R0P5)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Takhzyro - Takeda
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 275 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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51 adverse events reported
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