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
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 |
---|---|---|---|---|
AMVUTTRA | Alnylam Pharmaceuticals | N-215515 RX | 2022-06-13 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
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amvuttra | New Drug Application | 2022-06-21 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
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VUTRISIRAN SODIUM, AMVUTTRA, ALNYLAM PHARMS INC | |||
2029-06-13 | ODE-212 | ||
2027-06-13 | NCE |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Vutrisiran Sodium, Amvuttra, Alnylam Pharms Inc | |||
10208307 | 2036-07-28 | DS, DP | U-3396 |
10683501 | 2036-07-28 | DS, DP | U-3396 |
11286486 | 2036-07-28 | DS, DP | U-3396 |
10612024 | 2035-08-14 | DS, DP | U-3396 |
11401517 | 2035-08-14 | DS, DP | U-3396 |
9399775 | 2032-11-16 | DS, DP | U-3396 |
10570391 | 2032-11-16 | DS, DP | U-3396 |
8106022 | 2029-12-12 | DS, DP | U-3396 |
8828956 | 2028-12-04 | DS, DP | U-3396 |
9370581 | 2028-12-04 | DS, DP | U-3396 |
10806791 | 2028-12-04 | DP | |
10131907 | 2028-08-24 | DS, DP | U-3396 |
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
3 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
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Familial amyloidosis | D028226 | — | — | 1 | — | — | 1 | ||
Takotsubo cardiomyopathy | D054549 | EFO_1002000 | I51.81 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
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 name | VUTRISIRAN |
INN | vutrisiran |
Description | Vutrisiran, previously known as (ALN-TTRSC02), 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.
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Classification | Oligonucleotide |
Drug class | — |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
PDB | — |
CAS-ID | 1867157-35-4 |
RxCUI | — |
ChEMBL ID | CHEMBL4594511 |
ChEBI ID | — |
PubChem CID | — |
DrugBank | DB16699 |
UNII ID | GB4I2JI8UI (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
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Variants
Clinical Variant
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Financial
Amvuttra - Alnylam Pharmaceuticals
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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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