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Scheduling delegate's final decisions, June 2017

Scheduling medicines and poisons

29 June 2017

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4.3 Dupilumab

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

New Chemical Entities – medicines for human therapeutic use

4.3 Dupilumab

Scheduling proposal

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

Substance summary

Dupilumab is an immunoglobulin G4-kappa, anti-[Homo sapiens IL4R (interleukin 4 receptor, IL4RA, IL-4RA, CD124)], Homo sapiens monoclonal antibody (mAb) produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture.

Dupilumab is a fully human mAb that inhibits IL-4 and IL-13 signalling by specifically binding to the IL-4Rα subunit of the IL-4 and IL-13 receptor complexes. Dupilumab inhibits IL-4 signalling via the Type I receptor (IL 4Rα/γc), and both IL-4 and IL 13 signalling through the Type II receptor (IL-4Rα/IL-13Rα).

Dupilumab is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupilumab can be used with or without topical therapy.

Table 4.3: Identifiers, properties and naming of Dupilumab
Property Dupilumab
CAS Number 1190264-60-8
Structure Dupilumab structure
Molecular formula C6512H10066N1730O2052S46
Molecular weight 146.9 kDa
Other name/s FDA UNII: 420K487FSG
Scheduling status

Dupilumab is not specifically scheduled in the current Poisons Standard but is captured by the following group entry:

Schedule 4

MONOCLONAL ANTIBODIES for therapeutic use except:

  1. in diagnostic test kits; or
  2. when separately specified in these Schedules.
International regulations

Dupilumab is unclassified in New Zealand and Canada, but it is currently under review by the FDA in the USA (Sept, 2016).

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; 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 dupilumab in Schedule 4, with an implementation date of 1 October 2017.

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

Schedule 4 – New Entry

DUPILUMAB.

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; and (c) the toxicity of a substance.

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

  • Dupilumab is an NCE with no clinical experience in Australia.
  • Dupilumab is intended to treat moderate to severe atopic dermatitis.
  • There is potential for increased infection, possible interference with immune response to vaccines and a theoretical risk that it may increase potential for malignancy.
  • The potential for abuse of dupilumab is unlikely.

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