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Scheduling delegate's final decisions, January 2017

Scheduling medicines and poisons

16 January 2017

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2.10. Lipegfilgrastim

Final decisions on matters not referred to an expert advisory committee

2. New Chemical Entities – medicines for human therapeutic use

2.10. Lipegfilgrastim

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration for the scheduling of lipegfilgrastim, a NCE for a human therapeutic medicine.

Substance summary

Lipegfilgrastim is a long-acting covalent conjugate of filgrastim with methoxy polyethylene glycol (PEG) via a carbohydrate linker.

Lipegfilgrastim is indicated for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.

AAN – Lipegfilgrastim

Scheduling status

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

International regulations

Lipegfilgrastim is not classified in New Zealand.

Delegate's consideration

The delegate made a delegate-only decision; hence 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 lipegfilgrastim in Schedule 4, with an implementation date of 1 February 2017.

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

Schedule 4 – New Entry

LIPEGFILGRASTIM.

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.

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

  • It is a NCE with no clinical/marketing experience in Australia;
  • the condition being treated (neutropenia or febrile neutropenia) necessitates an appropriate diagnosis for the use of this medicine, and for ongoing patient management and monitoring, by a medical professional; and
  • The potential for abuse of lipegfilgrastim is unlikely.

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