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Final decisions and reasons for NCEs, medicines and chemicals, November 2018

Scheduling medicines and poisons

26 April 2019

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4.6. Semaglutide

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

4. New Chemical Entities - medicines for human therapeutic use

4.6. Semaglutide

Note

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Delegate's final decision
Final decision

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

Schedule 4 - New Entry

SEMAGLUTIDE

Index - New Entry

SEMAGLUTIDE

Schedule 4

Implementation date

1 June 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 biological 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:

    Semaglutide is a long-acting glucagon like peptide-1 (GLP-1) receptor agonist (GLP=1RA), with suggested indication for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:

    • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
    • in addition to other medicinal products for the treatment of type 2 diabetes
  3. the toxicity of a substance:

    No known major/serious toxicities

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

    No specific requirements over existing regulations and guidelines

  5. the potential for abuse of a substance:

    Unlikley

  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 semaglutide, a new chemical entity (NCE) for a human therapeutic medicine.

Scheduling status

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

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.

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