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| Stem definition | Drug id | CAS RN |
|---|---|---|
| enzymes | 5340 | None |
| Molecule | Description |
|---|---|
|
Synonyms:
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The active substance in Palynziq, pegvaliase, is a bacterial enzyme that can break down phenylalanine, thereby stopping phenylalanine from building up in the body and helping to relieve the symptoms of phenylketonuria. The enzyme in pegvaliase is ‘pegylated’ (attached to a chemical called PEG), allowing it to remain in the body and to act for longer
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 3, 2019 | EMA | BIOMARIN INTERNATIONAL LIMITED | |
| May 24, 2018 | FDA | BIOMARIN PHARM | |
| March 27, 2023 | PMDA | BioMarin Pharmaceutical Japan 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 |
|---|---|---|---|---|---|---|
| Amino acid level decreased | 167.84 | 50.87 | 20 | 1708 | 68 | 90626651 |
| Injection site erythema | 136.86 | 50.87 | 56 | 1672 | 98446 | 90528273 |
| Arthralgia | 131.99 | 50.87 | 112 | 1616 | 778410 | 89848309 |
| Anaphylactic reaction | 115.53 | 50.87 | 48 | 1680 | 87476 | 90539243 |
| Injection site reaction | 109.86 | 50.87 | 47 | 1681 | 92033 | 90534686 |
| Injection site swelling | 103.86 | 50.87 | 40 | 1688 | 59799 | 90566920 |
| Amino acid level increased | 82.06 | 50.87 | 13 | 1715 | 444 | 90626275 |
| Urticaria | 76.13 | 50.87 | 56 | 1672 | 312678 | 90314041 |
| Maternal exposure during pregnancy | 75.58 | 50.87 | 59 | 1669 | 360004 | 90266715 |
| Injection site pruritus | 65.81 | 50.87 | 28 | 1700 | 53806 | 90572913 |
| Amino acid level abnormal | 64.75 | 50.87 | 7 | 1721 | 6 | 90626713 |
| Injection site rash | 63.64 | 50.87 | 22 | 1706 | 24151 | 90602568 |
| Injection site pain | 51.13 | 50.87 | 35 | 1693 | 173664 | 90453055 |
| 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 |
|---|---|---|---|---|---|---|
| Arthralgia | 176.93 | 64.07 | 99 | 1300 | 205139 | 42414797 |
| Amino acid level decreased | 168.11 | 64.07 | 23 | 1376 | 151 | 42619785 |
| Amino acid level increased | 143.26 | 64.07 | 23 | 1376 | 490 | 42619446 |
| Anaphylactic reaction | 109.66 | 64.07 | 44 | 1355 | 42699 | 42577237 |
| Injection site erythema | 108.92 | 64.07 | 36 | 1363 | 20159 | 42599777 |
| Injection site reaction | 105.11 | 64.07 | 33 | 1366 | 15688 | 42604248 |
| Injection site swelling | 90.45 | 64.07 | 30 | 1369 | 16943 | 42602993 |
| Urticaria | 89.43 | 64.07 | 45 | 1354 | 73991 | 42545945 |
| Injection site rash | 83.19 | 64.07 | 22 | 1377 | 5690 | 42614246 |
| 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 |
|---|---|---|---|---|---|---|
| Anaphylactic reaction | 218.97 | 57.49 | 84 | 2225 | 114216 | 110472774 |
| Arthralgia | 167.83 | 57.49 | 134 | 2175 | 779498 | 109807492 |
| Injection site erythema | 151.25 | 57.49 | 61 | 2248 | 94115 | 110492875 |
| Amino acid level decreased | 144.55 | 57.49 | 17 | 2292 | 44 | 110586946 |
| Injection site reaction | 137.18 | 57.49 | 56 | 2253 | 89014 | 110497976 |
| Injection site swelling | 127.36 | 57.49 | 48 | 2261 | 61742 | 110525248 |
| Throat tightness | 106.86 | 57.49 | 36 | 2273 | 33453 | 110553537 |
| Amino acid level increased | 93.20 | 57.49 | 16 | 2293 | 820 | 110586170 |
| Urticaria | 92.83 | 57.49 | 66 | 2243 | 318791 | 110268199 |
| Injection site rash | 81.95 | 57.49 | 27 | 2282 | 23392 | 110563598 |
| Injection site pruritus | 71.25 | 57.49 | 30 | 2279 | 51228 | 110535762 |
| Dizziness | 58.30 | 57.49 | 72 | 2237 | 698121 | 109888869 |
None
| Source | Code | Description |
|---|---|---|
| ATC | A16AB19 | ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Enzymes |
| FDA CS | M0016545 | Phenylalanine Ammonia-Lyase |
| FDA EPC | N0000193858 | Phenylalanine Metabolizing Enzyme |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Classical phenylketonuria | indication | 7573000 |
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| ID | Source |
|---|---|
| N6UAH27EUV | UNII |
| 4037606 | VANDF |
| C4519229 | UMLSCUI |
| CHEBI:230846 | CHEBI |
| CHEMBL4297802 | ChEMBL_ID |
| 86278362 | PUBCHEM_CID |
| DB12839 | DRUGBANK_ID |
| D11077 | KEGG_DRUG |
| 9875 | INN_ID |
| C000629004 | MESH_SUPPLEMENTAL_RECORD_UI |
| 770965008 | SNOMEDCT_US |
| 771573001 | SNOMEDCT_US |
| 279595 | MMSL |
| 34260 | MMSL |
| d08799 | MMSL |
| 017571 | NDDF |
| 1585984-95-7 | SECONDARY_CAS_RN |
| 2046360 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Palynziq | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68135-058 | INJECTION, SOLUTION | 2.50 mg | SUBCUTANEOUS | BLA | 33 sections |
| Palynziq | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68135-058 | INJECTION, SOLUTION | 2.50 mg | SUBCUTANEOUS | BLA | 33 sections |
| Palynziq | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68135-673 | INJECTION, SOLUTION | 20 mg | SUBCUTANEOUS | BLA | 33 sections |
| Palynziq | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68135-673 | INJECTION, SOLUTION | 20 mg | SUBCUTANEOUS | BLA | 33 sections |
| Palynziq | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68135-756 | INJECTION, SOLUTION | 10 mg | SUBCUTANEOUS | BLA | 33 sections |
| Palynziq | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68135-756 | INJECTION, SOLUTION | 10 mg | SUBCUTANEOUS | BLA | 33 sections |