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Part B - Final decisions on matters not referred to an expert advisory committee
5. New Chemical Entities - medicines for human therapeutic use
5.5 Pibrentasvir
Delegate's final decision
Final decision:
The delegate has made a final decision to create a new Schedule 4 entry for pibrentasvir in the Poisons Standard as follows:
Schedule 4 - New Entry
PIBRENTASVIR.
Implementation date: 1 June 2018
Reasons:
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate include:
- the risks and benefits of the use of a substance
- Pibrentasvir is a new chemical entity with no clinical/marketing experience in Australia.
- the purposes for which a substance is to be used and the extent of use of a substance
- Pibrentasvir co-formulated with glecaprevir is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults.
- the toxicity of a substance
- Reported adverse events from clinical trials include headache, fatigue, and nausea.
- the dosage, formulation, labelling, packaging and presentation of a substance
- The fixed dose combination tablets pibrentasvir co-formulated with glecaprevir should be prescribed by medical professionals who are familiar with the management of viral hepatitis. The patients need to be instructed to follow the dosing regimens.
- the potential for abuse of a substance
- Nil.
- any other matters that the Secretary considers necessary to protect public health
- Nil.
Scheduling proposal
The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of pibrentasvir, a new chemical entity (NCE) for a human therapeutic medicine.
Substance summary
Pibrentasvir is a pangenotypic inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly. The mechanism of action of pibrentasvir has been characterised based on cell culture antiviral activity and drug resistance mapping studies.
Pibrentasvir, co-formulated with glecaprevir is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults.
| Property | Pibrentasvir |
|---|---|
| CAS Number | 1353900-92-1 |
| Chemical structure |  |
| Molecular formula | C57H65F5N10O8 |
| Molecular weight | 1113.2 g/mol |
| Chemical names | methyl {(2S,3R)-1-[(2S)-2-{5-[(2R,5R)-1-{3,5-difluoro-4-[4-(4-fluorophenyl)piperidin-1-yl]phenyl}-5-(6-fluoro-2-{(2S)-1-[N-(methoxycarbonyl)-O-methyl-L-threonyl]pyrrolidin-2-yl}-1H-benzimidazol-5-yl)pyrrolidin-2-yl]-6-fluoro-1H-benzimidazol-2-yl}pyrrolidin-1-yl]-3-methoxy-1-oxobutan-2-yl}carbamate. |
| ANN/INN |
eBS ID: 111198 ANN and INN: Pibrentasvir |
Scheduling status
Pibrentasvir is not specifically scheduled in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) - the Poisons Standard that was in effect at the time the decision was made (Poisons Standard March 2018 (SUSMP No. 20)).
International regulations
Pibrentasvir is approved in the USA as a prescription medicine.
Pibrentasvir is unclassified in New Zealand and Canada.
Delegate's considerations
The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.
The delegate considered the following in regards to this application for scheduling:
- Subsection 52E(1) of the Therapeutic Goods Act 1989;
- The Scheduling Policy Framework 2015 scheduling factors; and
- The TGA evaluation report;
- The advice of the Advisory Committee on Prescription Medicines;
- The new drug application; and
- Other.
The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.