This brand name is authorized in United States.
The drug QALSODY contains one active pharmaceutical ingredient (API):
1
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UNII
2NU6F9601K - TOFERSEN
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SOD1-ALS is a primarily autosomal-dominant disorder affecting approximately 2% of the ALS population. Mutations in the SOD1 gene lead to accumulation of a toxic form of SOD1 protein. Tofersen is an antisense oligonucleotide (ASO) that is complementary to a portion of the 3′ untranslated region (3′UTR) of the mRNA for human SOD1 and binds to the mRNA by Watson-Crick base pairing (hybridisation). This hybridisation of tofersen to the cognate mRNA results in RNase-Hmediated degradation of the mRNA for SOD1, which reduces the amount of SOD1 protein synthesis. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| QALSODY Solution for injection | MPI, US: SPL/PLR | FDA, National Drug Code (US) | |
| QALSODY Solution for injection | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| N07XX22 | N Nervous system → N07 Other nervous system drugs → N07X Other nervous system drugs → N07XX Other nervous system drugs | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| US | FDA, National Drug Code | 64406-109 |
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