Stem definition | Drug id | CAS RN |
---|---|---|
antivirals, hepatitis C Virus (HCV) NS5A inhibitors | 5244 | 1353900-92-1 |
None
None
Date | Agency | Company | Orphan |
---|---|---|---|
July 26, 2017 | EMA | AbbVie Deutschland GmbH & Co. KG | |
Aug. 3, 2017 | FDA | ABBVIE INC |
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 |
---|---|---|---|---|---|---|
Headache | 977.12 | 32.60 | 630 | 4883 | 477722 | 46202827 |
Fatigue | 971.84 | 32.60 | 687 | 4826 | 608010 | 46072539 |
Pruritus | 471.87 | 32.60 | 313 | 5200 | 242039 | 46438510 |
Nausea | 317.13 | 32.60 | 393 | 5120 | 687061 | 45993488 |
Blood bilirubin increased | 95.56 | 32.60 | 56 | 5457 | 34128 | 46646421 |
Product dose omission issue | 86.87 | 32.60 | 103 | 5410 | 168417 | 46512132 |
Therapy cessation | 47.80 | 32.60 | 33 | 5480 | 26596 | 46653953 |
Wrong schedule | 46.58 | 32.60 | 9 | 5504 | 150 | 46680399 |
Jaundice | 43.17 | 32.60 | 32 | 5481 | 28813 | 46651736 |
Rash | 40.14 | 32.60 | 112 | 5401 | 356400 | 46324149 |
Hepatocellular carcinoma | 38.60 | 32.60 | 14 | 5499 | 2825 | 46677724 |
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 |
---|---|---|---|---|---|---|
Fatigue | 1494.91 | 28.05 | 864 | 5187 | 319809 | 29626618 |
Headache | 1448.42 | 28.05 | 704 | 5347 | 181602 | 29764825 |
Nausea | 226.58 | 28.05 | 287 | 5764 | 296670 | 29649757 |
Pruritus | 156.46 | 28.05 | 153 | 5898 | 118051 | 29828376 |
Hepatocellular carcinoma | 95.40 | 28.05 | 44 | 6007 | 9566 | 29936861 |
Blood bilirubin increased | 71.10 | 28.05 | 59 | 5992 | 36577 | 29909850 |
Product dose omission issue | 64.98 | 28.05 | 86 | 5965 | 91545 | 29854882 |
Hepatic cirrhosis | 63.97 | 28.05 | 40 | 6011 | 15959 | 29930468 |
Therapy cessation | 58.40 | 28.05 | 37 | 6014 | 15100 | 29931327 |
Abdominal discomfort | 53.07 | 28.05 | 57 | 5994 | 48734 | 29897693 |
Hepatitis C | 52.75 | 28.05 | 33 | 6018 | 13172 | 29933255 |
Child-Pugh-Turcotte score increased | 36.55 | 28.05 | 7 | 6044 | 62 | 29946365 |
Diarrhoea | 36.24 | 28.05 | 148 | 5903 | 333955 | 29612472 |
Viral load increased | 34.48 | 28.05 | 15 | 6036 | 2839 | 29943588 |
Jaundice | 31.91 | 28.05 | 36 | 6015 | 32450 | 29913977 |
Source | Code | Description |
---|---|---|
ATC | J05AP57 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections |
FDA MoA | N0000182138 | Cytochrome P450 1A2 Inhibitors |
FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
FDA MoA | N0000190107 | Organic Anion Transporting Polypeptide 1B1 Inhibitors |
FDA MoA | N0000190108 | Organic Anion Transporting Polypeptide 1B3 Inhibitors |
FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
FDA MoA | N0000190114 | Cytochrome P450 3A Inhibitors |
FDA EPC | N0000191256 | Hepatitis C Virus NS5A Inhibitor |
FDA MoA | N0000191272 | UGT1A1 Inhibitors |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Chronic hepatitis C | indication | 128302006 |
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 11.04 | acidic |
pKa2 | 11.64 | acidic |
pKa3 | 12.69 | acidic |
pKa4 | 13.29 | acidic |
pKa5 | 5.17 | Basic |
pKa6 | 4.56 | Basic |
pKa7 | 1.2 | Basic |
None
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
100MG;40MG | MAVYRET | ABBVIE INC | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | Aug. 6, 2021 | REVISIONS TO THE GLECAPREVIR/PIBRENTASVIR COMBINULLTION PRODUCT PRESCRIBING INFORMATION TO INCLUDE SAFETY AND EFFICACY DATA FROM THE HCV/HIV-1 COINFECTION STUDY M14-730 AND FROM THE LIVER AND RENULLL TRANSPLANT STUDY M13-596 |
100MG;40MG | MAVYRET | ABBVIE INC | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | April 30, 2022 | NEW PATIENT POPULATION |
100MG;40MG | MAVYRET | ABBVIE INC | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | Aug. 3, 2022 | NEW CHEMICAL ENTITY |
100MG;40MG | MAVYRET | ABBVIE INC | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | Sept. 26, 2022 | EIGHT-WEEK DOSING REGIMEN FOR THE TREATMENT OF GENOTYPES 1, 2, 3, 4, 5, AND 6, CHRONIC HEPATITIS C VIRUS INFECTION IN TREATMENT-NULLIVE SUBJECTS WITH COMPENSATED CIRRHOSIS BASED ON THE RESULTS FROM THE EXPEDITION-8 STUDY |
100MG;40MG | MAVYRET | ABBVIE INC | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | Oct. 30, 2022 | PEDIATRIC EXCLUSIVITY |
100MG;40MG | MAVYRET | ABBVIE INC | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | Feb. 3, 2023 | PEDIATRIC EXCLUSIVITY |
100MG;40MG | MAVYRET | ABBVIE INC | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | March 26, 2023 | PEDIATRIC EXCLUSIVITY |
100MG;40MG | MAVYRET | ABBVIE INC | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | April 10, 2023 | INFORMATION ADDED TO THE LABELING REGARDING SAFETY AND EFFICACY IN SUBJECTS WITH HCV SUBTYPE 3B INFECTION |
100MG;40MG | MAVYRET | ABBVIE INC | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | Oct. 10, 2023 | PEDIATRIC EXCLUSIVITY |
100MG;40MG | MAVYRET | ABBVIE INC | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | April 30, 2026 | TREATMENT OF PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1,2,3,4,5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS (CHILD-PUGH A) |
100MG;40MG | MAVYRET | ABBVIE INC | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | April 30, 2026 | TREATMENT OF PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG WITH HCV GENOTYPE 1 INFECTION, WHO PREVIOUSLY HAVE BEEN TREATED WITH A REGIMEN CONTAINING AN HCV NS5A INHIBITOR OR AN NS3/4A PROTEASE INHIBITOR (PI), BUT NOT BOTH |
100MG;40MG | MAVYRET | ABBVIE INC | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | Oct. 30, 2026 | PEDIATRIC EXCLUSIVITY |
None
ID | Source |
---|---|
4036872 | VANDF |
C4310001 | UMLSCUI |
CHEMBL3545123 | ChEMBL_ID |
58031952 | PUBCHEM_CID |
D10816 | KEGG_DRUG |
DB13878 | DRUGBANK_ID |
C000612854 | MESH_SUPPLEMENTAL_RECORD_UI |
11268 | IUPHAR_LIGAND_ID |
C000622691 | MESH_SUPPLEMENTAL_RECORD_UI |
10260 | INN_ID |
2WU922TK3L | UNII |
1940636 | RXNORM |
33001 | MMSL |
d08634 | MMSL |
017296 | NDDF |
736836002 | SNOMEDCT_US |
816102004 | SNOMEDCT_US |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Mavyret | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0074-2600 | PELLET | 20 mg | ORAL | NDA | 32 sections |
Mavyret | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0074-2625 | TABLET, FILM COATED | 40 mg | ORAL | NDA | 32 sections |