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tofersen 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antisense oligonucleotides | 5733 | 2088232-70-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Tofersen is an antisense oligonucleotide that causes degradation of SOD1 mRNA through binding to SOD1 mRNA, which results in a reduction of SOD1 protein synthesis.
|
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 25, 2023 | FDA | BIOGEN MA |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Post lumbar puncture syndrome | 86.96 | 62.92 | 11 | 145 | 1086 | 110588057 |
| CSF protein increased | 83.58 | 62.92 | 11 | 145 | 1480 | 110587663 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N07XX22 | NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs |
| FDA CS | M0025055 | Oligonucleotides, Antisense |
| FDA EPC | N0000191626 | Antisense Oligonucleotide |
Related Drugs by ATC class:
N07XX Other nervous system drugs 23 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Amyotrophic lateral sclerosis | indication | 86044005 | DOID:332 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 100MG/15ML (6.7MG/ML) | QALSODY | BIOGEN MA | N215887 | April 25, 2023 | RX | SOLUTION | INTRATHECAL | 10669546 | April 1, 2035 | TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS WHO HAVE A MUTATION IN THE SUPEROXIDE DISMUTASE 1 (SOD1) GENE |
| 100MG/15ML (6.7MG/ML) | QALSODY | BIOGEN MA | N215887 | April 25, 2023 | RX | SOLUTION | INTRATHECAL | 10968453 | April 1, 2035 | TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS WHO HAVE A MUTATION IN THE SUPEROXIDE DISMUTASE 1 (SOD1) GENE |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 100MG/15ML (6.7MG/ML) | QALSODY | BIOGEN MA | N215887 | April 25, 2023 | RX | SOLUTION | INTRATHECAL | April 25, 2028 | NEW CHEMICAL ENTITY |
| 100MG/15ML (6.7MG/ML) | QALSODY | BIOGEN MA | N215887 | April 25, 2023 | RX | SOLUTION | INTRATHECAL | April 25, 2030 | TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS WHO HAVE A MUTATION IN THE SUPEROXIDE DISMUTASE 1 (SOD1) GENE |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Superoxide dismutase 1 (SOD1) mRNA | RNA | BINDING AGENT | UNKNOWN | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEBI:755937 | CHEBI |
| CHEMBL3833346 | ChEMBL_ID |
| C000709090 | MESH_SUPPLEMENTAL_RECORD_UI |
| 13536 | IUPHAR_LIGAND_ID |
| DB14782 | DRUGBANK_ID |
| 44941311000001100 | SNOMEDCT_US |
| 4042212 | VANDF |
| C5139925 | UMLSCUI |
| CHEMBL4297234 | ChEMBL_ID |
| 10804 | INN_ID |
| 1898254-60-8 | SECONDARY_CAS_RN |
| 366714 | MMSL |
| 41435 | MMSL |
| d10039 | MMSL |
| 019401 | NDDF |
| D11811 | KEGG_DRUG |
| 2NU6F9601K | UNII |
| 2634995 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| QALSODY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64406-109 | INJECTION | 100 mg | INTRATHECAL | NDA | 25 sections |