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Scheduling delegate's final decisions, June 2016

Scheduling of medicines and poisons

23 June 2016

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5.1 Ixekizumab

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

5. New Chemical Entities - medicines for human therapeutic use

5.1 Ixekizumab

Delegate's Scheduling proposal

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

Substance summary

Ixekizumab is a humanised monoclonal antibody against the pro-inflammatory cytokine interleukin-17A (IL-17A).

Ixekizumab is indicated for the treatment of adult patients with moderate to severe plaque psoriasis.

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

Scheduling status

Ixekizumab 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 proposal:

  • 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 Poisons Standard to include ixekizumab 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 are (a) the risks and benefits of the use of a substance; (b) the purpose and the extent of use of a substance; (c) the toxicity of a substance; and d) the dosage, formulation, labelling, packaging and presentation 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 or marketing experience in Australia.
  • The product suppresses the immune system and requires ongoing monitoring for infection and other serious side effects.
  • Product is administered via subcutaneous injection.

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

Schedule 4 - New Entry

IXEKIZUMAB.

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