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Scheduling delegate's final decisions, January 2018

Scheduling medicines and poisons

25 January 2018

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1.9. Ertugliflozin

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of ertugliflozin, a new chemical entity (NCE) for a human therapeutic medicine.

Substance summary

Ertugliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. It reduces blood glucose levels by increasing renal excretion of glucose.

Ertugliflozin is indicated for the treatment of type 2 diabetes.

Scheduling status

Ertugliflozin is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) – the Poisons Standard that was in effect at the time the decision was made (Poisons Standard October 2017 (SUSMP No. 18)). However, there are a number of other similar medicines of this class of agents known as SGLT-2 inhibitors in Schedule 4, e.g. empagliflozin, canagliflozin and dapagliflozin.

International regulations

Ertugliflozin is classified as a prescription medicine in the United States of America.

Delegate’s consideration

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

  • 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 (2015) scheduling factors;
  • The TGA evaluation report;
  • The advice of the Advisory Committee on Prescription Medicines; and
  • 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 ertugliflozin in Schedule 4, with an implementation date of 1 February 2018.

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

Schedule 4 – New Entry

ERTUGLIFLOZIN.

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; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (e) the potential for abuse.

The delegate decided that the reasons for the final decision comprise the following:

  • Ertugliflozin is an NCE with no clinical or marketing experience in Australia.
  • There are a number of other similar medicines of this class of agents known as SGLT-2 inhibitors in Schedule 4.
  • Ertugliflozin will be prescribed by medical practitioners for the management of type 2 diabetes when metformin and dietary measures and/or other medicines are unable to control blood glucose levels.
  • There are no major serious toxicities.
  • No specific requirements over existing regulations and guidelines.

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