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Final decisions amending, or not amending, the current Poisons Standard, April 2018

Scheduling medicines and poisons

10 April 2018

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5.5 Pibrentasvir

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:

  1. the risks and benefits of the use of a substance
    • Pibrentasvir is a new chemical entity with no clinical/marketing experience in Australia.
  2. 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.
  3. the toxicity of a substance
    • Reported adverse events from clinical trials include headache, fatigue, and nausea.
  4. 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.
  5. the potential for abuse of a substance
    • Nil.
  6. 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.

Table 5.5.1: Identifiers, properties and naming of pibrentasvir
Property Pibrentasvir
CAS Number 1353900-92-1
Chemical structure chemical structure of pibrentasvir
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.

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