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Delegate-only final decisions and reasons: NCEs, September 2019

Scheduling of chemicals and poisons

25 September 2019

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1.3 Risankizumab

Final decisions on matters not referred to an expert advisory committee

1. New Chemical Entities - medicines for human therapeutic use

1.3 Risankizumab
Delegate's final decision

The delegate's final decision under regulation 42ZCZU of the Therapeutic Goods Regulations 1990 is to include risankizumab in Schedule 4 and Appendix K of the Poisons Standard as follows:

Schedule 4 - New Entry

RISANKIZUMAB.

Appendix K - New Entry

RISANKIZUMAB

Index - New Entry

RISANKIZUMAB

Schedule 4
Appendix K

Implementation date

1 October 2019

Reasons

The matters under subsection 52E(1) of the Therapeutic Goods Act 1989 considered relevant by the delegate for the decision include:

  1. the risks and benefits of the use of a substance:
    • It is a new chemical entity with no clinical or marketing experience in Australia.
  2. the purposes for which a substance is to be used and the extent of use of a substance:
    • Moderate to severe plaque psoriasis.
  3. the toxicity of a substance:
    • Potential toxicity is unknown.
  4. the dosage, formulation, labelling, packaging and presentation of a substance:
    • Substance requires subcutaneous injection.
  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 of the Secretary proposed to amend the Poisons Standard with respect to risankizumab, a new chemical entity (NCE) for a human therapeutic medicine.

Scheduling status

Risankizumab is not specifically scheduled in the Poisons Standard, but as a monoclonal antibody, it is captured by the Schedule 4 entry for monoclonal antibodies as follows:

Schedule 4

MONOCLONAL ANTIBODIES for therapeutic use except:

  1. in diagnostic test kits; or
  2. when separately specified in these Schedules.
Delegate's considerations
  • Advice on the place in therapy of this NCE;
  • Scheduling Policy Framework (SPF 2018); and
  • Section 52E(1) of the Therapeutic Goods Act 1989 in particular: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used 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.

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