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Drug ReportsVutrisiran
Amvuttra(vutrisiran)
Amvuttra (vutrisiran) is an oligonucleotide pharmaceutical. Vutrisiran was first approved as Amvuttra on 2022-06-13. It has been approved in Europe to treat familial amyloid neuropathies.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Amvuttra
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Vutrisiran sodium
Tradename
Company
Number
Date
Products
AMVUTTRAAlnylam PharmaceuticalsN-215515 RX2022-06-13
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
amvuttraNew Drug Application2023-01-27
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
VUTRISIRAN SODIUM, AMVUTTRA, ALNYLAM PHARMS INC
2029-06-13ODE-212
2027-06-13NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Vutrisiran Sodium, Amvuttra, Alnylam Pharms Inc
102083072036-07-28DS, DPU-3396
106835012036-07-28DS, DPU-3396
112864862036-07-28DS, DPU-3396
106120242035-08-14DS, DPU-3396
114015172035-08-14DS, DPU-3396
93997752032-11-16DS, DPU-3396
105703912032-11-16DS, DPU-3396
81060222029-12-12DS, DPU-3396
88289562028-12-04DS, DPU-3396
93705812028-12-04DS, DPU-3396
108067912028-12-04DP
101319072028-08-24DS, DPU-3396
ATC Codes
N: Nervous system drugs
— N07: Other nervous system drugs in atc
— N07X: Other nervous system drugs in atc
— N07XX: Other nervous system drugs in atc
— N07XX18: Vutrisiran
HCPCS
Code
Description
J0225
Injection, vutrisiran, 1 mg
Clinical
Clinical Trials
5 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
AmyloidosisD000686EFO_1001875E851—3—15
Familial amyloid neuropathiesD028227—E85.1——3——3
Familial amyloidosisD028226————1—12
Takotsubo cardiomyopathyD054549EFO_1002000I51.81——2——2
CardiomyopathiesD009202EFO_0000318I42——2——2
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PolyneuropathiesD011115EFO_0009562A69.22————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameVutrisiran
INNvutrisiran
Description
Vutrisiran, sold under the brand name Amvuttra, is a medication used for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. It is a double stranded small interfering RNA (siRNA) (also called RNA interference, or RNAi therapeutic) that interferes with the expression of the transthyretin (TTR) gene. Transthyretin is a serum protein made in the liver whose major function is transport of vitamin A and thyroxine. Rare mutations in the transthyretin gene result in accumulation of large amyloid deposits of misfolded transthyretin molecules most prominently in peripheral nerves and the heart. Patients with hATTR typically present with polyneuropathy or autonomic dysfunction followed by cardiomyopathy which, if untreated, is fatal within 5 to 10 years.
Classification
Oligonucleotide
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1867157-35-4
RxCUI—
ChEMBL IDCHEMBL4594511
ChEBI ID—
PubChem CID—
DrugBankDB16699
UNII IDGB4I2JI8UI (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Amvuttra – Alnylam Pharmaceuticals
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 338 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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505 adverse events reported
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