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| Stem definition | Drug id | CAS RN |
|---|---|---|
| natriuretic peptides | 5480 | 1480724-61-5 |
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 26, 2021 | EMA | BIOMARIN INTERNATIONAL LIMITED | |
| Nov. 19, 2021 | FDA | BIOMARIN PHARM | |
| June 20, 2022 | PMDA | BIOMARIN PHARMACEUTICAL K.K |
| 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 |
|---|---|---|---|---|---|---|
| Foramen magnum stenosis | 115.51 | 54.94 | 11 | 48 | 178 | 90628210 |
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| 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 |
|---|---|---|---|---|---|---|
| Foramen magnum stenosis | 152.32 | 55.52 | 12 | 94 | 3 | 110589190 |
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| Source | Code | Description |
|---|---|---|
| ATC | M05BX07 | MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Other drugs affecting bone structure and mineralization |
| FDA CS | M0029831 | Natriuretic Peptide, C-Type |
| FDA EPC | N0000193980 | C-type Natriuretic Peptide Analog |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Achondroplasia | indication | 86268005 | DOID:4480 |
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| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.4MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | RE48267 | May 20, 2030 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 0.56MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | RE48267 | May 20, 2030 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 1.2MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | RE48267 | May 20, 2030 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 0.4MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 8198242 | June 11, 2035 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 0.56MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 8198242 | June 11, 2035 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 1.2MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 8198242 | June 11, 2035 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 0.4MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 10646550 | Aug. 1, 2036 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 0.4MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 11590204 | Aug. 1, 2036 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 0.4MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 11911446 | Aug. 1, 2036 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 0.4MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 12514906 | Aug. 1, 2036 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 0.56MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 10646550 | Aug. 1, 2036 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 0.56MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 11590204 | Aug. 1, 2036 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 0.56MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 11911446 | Aug. 1, 2036 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 0.56MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 12514906 | Aug. 1, 2036 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 1.2MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 10646550 | Aug. 1, 2036 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 1.2MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 11590204 | Aug. 1, 2036 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 1.2MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 11911446 | Aug. 1, 2036 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 1.2MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 12514906 | Aug. 1, 2036 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 0.4MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 12233106 | July 11, 2042 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 0.56MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 12233106 | July 11, 2042 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 1.2MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 12233106 | July 11, 2042 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 0.4MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | Oct. 20, 2026 | NEW PATIENT POPULATION |
| 0.56MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | Oct. 20, 2026 | NEW PATIENT POPULATION |
| 1.2MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | Oct. 20, 2026 | NEW PATIENT POPULATION |
| 0.4MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | Nov. 19, 2026 | NEW CHEMICAL ENTITY |
| 0.56MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | Nov. 19, 2026 | NEW CHEMICAL ENTITY |
| 1.2MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | Nov. 19, 2026 | NEW CHEMICAL ENTITY |
| 0.4MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | Nov. 19, 2028 | TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES |
| 0.56MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | Nov. 19, 2028 | TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES |
| 1.2MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | Nov. 19, 2028 | TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES |
| 0.4MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | Oct. 20, 2030 | TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS LESS THAN 5 YEARS OF AGE WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 0.56MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | Oct. 20, 2030 | TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS LESS THAN 5 YEARS OF AGE WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| 1.2MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | Oct. 20, 2030 | TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS LESS THAN 5 YEARS OF AGE WITH ACHONDROPLASIA WITH OPEN EPIPHYSES |
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Atrial natriuretic peptide receptor 2 | Enzyme | ACTIVATOR | EC50 | 8.77 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| 7SE5582Q2P | UNII |
| C4519745 | UMLSCUI |
| CHEBI:755767 | CHEBI |
| CHEMBL3707276 | ChEMBL_ID |
| 119058036 | PUBCHEM_CID |
| DB11928 | DRUGBANK_ID |
| 10022 | INN_ID |
| C000632572 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9068 | IUPHAR_LIGAND_ID |
| D11190 | KEGG_DRUG |
| 1660971000168105 | SNOMEDCT_US |
| 1661051000168106 | SNOMEDCT_US |
| 4040998 | VANDF |
| 353929 | MMSL |
| 40117 | MMSL |
| d09828 | MMSL |
| 018891 | NDDF |
| 2586354 | RXNORM |
| 7SE5582Q2P | INXIGHT DRUGS |
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