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Scheduling delegate's final decisions, January 2018

Scheduling medicines and poisons

25 January 2018

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1.11. Insulin deglude

Scheduling proposal

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

Substance summary

Insulin degludec is a basal insulin with a slow and distinct absorption mechanism resulting in an ultra-long, flat, and stable pharmacokinetic profile in patients with diabetes mellitus.

Insulin degludec is indicated to improve glycaemic control in adult patients with diabetes mellitus.

Table E: Insulin degludec chemical information and naming
Property Insulin degludec
CAS number 844439-96-9
Chemical structure
Molecular formula C274H411N65O81S6
Molecular weight 6103.97 Da
Chemical names (1A-21A),(1B-29B)-Insulin (human), 29B-(N6-(N-(15-carboxy-1-oxopentadecyl)-L-gamma- glutamyl)-L-lysine)-
Other names Insulin degludec (human) (INN); Insulin degludec (ABN)

Scheduling status

Insulin degludec is not specifically scheduled but is captured by the Schedule 4 class entry for insulins 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)) as follows:

Schedule 4

INSULINS.

The similar substance, insulin glargine, is in Schedule 4 of the Poisons Standard as follows:

Schedule 4

INSULIN GLARGINE.

International regulations

Insulin degludec is not classified in New Zealand. Insulin degludec is listed under Schedule D in Canada and is listed as a prescription only medicine in the United States of America (USA) and the European Union (EU).

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; and
  • The TGA evaluation report.

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 insulin degludec 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

INSULIN DEGLUDEC.

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 (e) the potential for abuse.

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

  • Insulin degludec is an NCE with no clinical or marketing experience in Australia.
  • Insulin degludec has had clinical and marketing experience in the EU and USA.
  • Insulin degludec is similar to other long acting insulins available in Australia such as insulin glargine.
  • Insulin degludec is indicated to improve glycaemic control in adult patients with diabetes mellitus.
  • The toxicity of insulin degludec is minimal if used appropriately with blood glucose monitoring. Like other insulins if used inappropriately there is a risk of hypoglycaemia.
  • The potential for abuse of insulin degludec is unlikely.

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