Stem definition | Drug id | CAS RN |
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5457 | 2019171-69-6 |
Molecule | Description |
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Synonyms:
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Pegcetacoplan binds to complement protein C3 and its activation fragment C3b, thereby regulating the cleavage of C3 and the generation of downstream effectors of complement activation. In PNH, extravascular hemolysis (EVH) is facilitated by C3b opsonization while intravascular hemolysis (IVH) is mediated by the downstream membrane attack complex (MAC). Pegcetacoplan acts proximally in the complement cascade controlling both C3b-mediated EVH and terminal complement-mediated IVH.
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Date | Agency | Company | Orphan |
---|---|---|---|
Dec. 13, 2021 | EMA | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | |
May 14, 2021 | FDA | APELLIS PHARMACEUTICALS INC | |
March 27, 2023 | PMDA | Swedish Orphan Biovitrum Japan Co., Ltd. |
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Source | Code | Description |
---|---|---|
ATC | L04AA54 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants |
FDA EPC | N0000175575 | Complement Inhibitor |
FDA MoA | N0000175974 | Complement Inhibitors |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Paroxysmal nocturnal hemoglobinuria | indication | 1963002 | DOID:0060284 |
Geographic atrophy secondary to age-related macular degeneration | indication | 414875008 | |
Unresolved serious infection caused by Neisseria meningitidis | contraindication | 23511006 | |
Unresolved serious infection caused by Haemophilus influenzae | contraindication | 91428005 | |
Uveitis | contraindication | 128473001 | DOID:13141 |
Ocular or periocular infection | contraindication | 715266002 |
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Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | 9056076 | Oct. 25, 2026 | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN |
15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | 8168584 | April 7, 2027 | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN |
15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | 8168584 | April 7, 2027 | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN AND ALSO ADMINISTERING AN ANTI-VEGF AGENT |
1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 9169307 | Nov. 18, 2027 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF COMPLEMENT INHIBITOR PEGCETACOPLAN |
15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | 9169307 | Nov. 18, 2027 | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY ADMINISTERING COMPLEMENT INHIBITOR PEGCETACOPLAN |
1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11661441 | Jan. 13, 2033 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN |
15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | 11661441 | Jan. 13, 2033 | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN |
1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 10875893 | Nov. 15, 2033 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN |
1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11292815 | Nov. 15, 2033 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN |
1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11292815 | Nov. 15, 2033 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN SO AS TO REDUCE THE SENSITIVITY OF CELLS TO COMPLEMENT-DEPENDENT DAMAGE |
15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | 10875893 | Nov. 15, 2033 | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN |
15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | 11292815 | Nov. 15, 2033 | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN |
1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11040107 | April 9, 2038 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN |
1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11040107 | April 9, 2038 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN EVERY THREE DAYS |
1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11040107 | April 9, 2038 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN TWICE WEEKLY |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | Feb. 8, 2026 | INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF STUDY APL2-308 |
15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | Feb. 22, 2026 | NEW PRODUCT |
1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | May 14, 2026 | NEW CHEMICAL ENTITY |
15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | May 14, 2026 | NEW CHEMICAL ENTITY |
1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | May 14, 2028 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Complement C3 | Unclassified | INHIBITOR | IC50 | 6.60 | SCIENTIFIC LITERATURE | DRUG LABEL |
ID | Source |
---|---|
TO3JYR3BOU | UNII |
C5418501 | UMLSCUI |
CHEMBL4298211 | ChEMBL_ID |
DB16694 | DRUGBANK_ID |
10743 | INN_ID |
018732 | NDDF |
1162412004 | SNOMEDCT_US |
1162431005 | SNOMEDCT_US |
4040509 | VANDF |
2557372 | RXNORM |
346711 | MMSL |
39544 | MMSL |
d09749 | MMSL |
C000716074 | MESH_SUPPLEMENTAL_RECORD_UI |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Empaveli | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73606-010 | INJECTION, SOLUTION | 1080 mg | SUBCUTANEOUS | NDA | 31 sections |
Empaveli | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73606-010 | INJECTION, SOLUTION | 1080 mg | SUBCUTANEOUS | NDA | 31 sections |
Syfovre | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73606-020 | INJECTION, SOLUTION | 15 mg | INTRAVITREAL | NDA | 27 sections |