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Final scheduling decisions and reasons: NCEs and Appendix H

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

12 December 2018

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2.1. Crisaborole

2. New Chemical Entities (NCEs) - medicines for human therapeutic use

2.1. Crisaborole

Delegate's final decision
Final decision:

The delegate's final decision is to amend the Poisons Standard to include crisaborole in Schedule 4 as follows:

Schedule 4 - New Entry

CRISABOROLE

Index - New Entry

CRISABOROLE

Schedule 4

Proposed implementation date:

1 February 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:

    Crisaborole is a phosphodiesterase-4 (PDE-4) inhibitor and is developed for topical treatment of mild to moderate atopic dermatitis (AD). The specific mechanism(s) by which crisaborole exerts its therapeutic action is not well defined. In these uses the benefits are considered to outweigh risks at a population level (pending ACM review).

  2. the purposes for which a substance is to be used and the extent of use of a substance:

    Topical treatment of mild to moderate atopic dermatitis in patients 2 years of age and older.

  3. the toxicity of a substance:

    Crisaborole has its own distinct toxicities but these have been addressed within the benefit/risk consideration noted above.

  4. the dosage, formulation, labelling, packaging and presentation of a substance:

    The dose regimen, formulation, labelling, packaging and presentation of crisaborole have been considered and none of these aspects precludes scheduling of crisaborole as Schedule 4.

  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 crisaborole.

Scheduling status

Crisaborole is not specifically scheduled and is not captured by any entry in the Poisons Standard.

Delegate's considerations

The delegate considered the following in regards to this scheduling:

  • Subsection 52E(1) of the Therapeutic Goods Act 1989;
  • The Scheduling Policy Framework (2018) scheduling factors;
  • The TGA evaluation report;
  • The advice of the Advisory Committee on Medicines;
  • The new drug application.

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