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Scheduling delegate's final decisions, June 2016

Scheduling of medicines and poisons

23 June 2016

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5.6 Pirfenidone

Part B - Final decisions on matters not referred to an expert advisory committee

5. New Chemical Entities - medicines for human therapeutic use

5.6 Pirfenidone

Delegate's Scheduling proposal

The delegate considered an application from the TGA for the scheduling of pirfenidone, a new chemical entity for a human therapeutic medicine.

Substance summary

Pirfenidone exerts both anti-fibrotic and anti-inflammatory properties in a variety of in vitro systems and animal models of pulmonary fibrosis (bleomycin- and transplant induced fibrosis). IPF is a chronic fibrotic and inflammatory pulmonary disease affected by the synthesis and release of pro- inflammatory cytokines including tumour necrosis factor-alpha (TNF-α) and interleukin-1-beta (IL 1β) and the substance has been shown to reduce the accumulation of inflammatory cells in response to various stimuli.

Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

Scheduling status

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

Delegate's interim decision

The delegate decided to make a delegate-only decision to include this to Schedule 4. The Advisory Committee on Medicines Scheduling was not consulted.

Delegate's considerations

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 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 pirfenidone in Schedule 4, with an implementation date of 1 October 2016.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 is (a) the risks and benefits of the use of a substance.

The delegate decided that the reason for the final decision comprises the following:

  • It is a new chemical entity with no [clinical/marketing] experience in Australia.

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

Schedule 4 - New Entry


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