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Scheduling delegate's final decisions: NCEs, April 2016

Scheduling of medicines and poisons

28 April 2016

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1.5 Grazoprevir

Final decisions on matters not referred to an expert advisory committee

1. New Chemical Entities - medicines for human therapeutic use

1.5 Grazoprevir

Scheduling proposal

The proposal is to include grazoprevir, a new chemical entity for a human therapeutic medicine, in Schedule 4 of the SUSMP.

Scheduling application

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of grazoprevir, a new chemical entity for a human therapeutic medicine.

The Advisory Committee on Medicines Scheduling was not consulted.

Substance summary

Grazoprevir is a second generation HCV NS3/4A protease inhibitor (PI).

Grazoprevir is indicated for the treatment of Chronic Hepatitis C infection in adults.

Scheduling status

Grazoprevir is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons.

Grazoprevir is not classified in New Zealand.

Delegate's consideration

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 scheduling factors
  • The TGA evaluation report
  • The new drug application

The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.

Delegate's final decision

The delegate has made a final decision to amend the SUSMP to include grazoprevir in Schedule 4, with an implementation date of 1 June 2016.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) the risks and benefits of the use of a substance; (b) the purpose and the extent of use of a substance; and (c) the toxicity of a substance.

The delegate decided that the reasons for the final decision comprise the following:

  • It is a new chemical entity with no clinical/marketing experience in Australia.
  • Treatment of serious chronic infection.
  • Safety data still quite limited so monitoring is required.

The delegate has decided that the wording for the schedule entry will be as follows:

Schedule entry

Schedule 4 - New Entry

GRAZOPREVIR

Implementation date: 1 June 2016.

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