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Scheduling delegate's final decisions, January 2018

Scheduling medicines and poisons

25 January 2018

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1.17. Reslizumab

Scheduling proposal

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

Substance summary

Reslizumab is a humanized anti-human interleukin 5 monoclonal antibody (anti IL-5 mAb) of the immunoglobulin-G4-kappa (IgG4/k) isotope, produced in mouse myeloma cells (NS0) by recombinant DNA technology. Reslizumab works by binding to IL-5, thereby preventing binding of IL-5 to the IL-5 receptor and consequently reduces circulating and tissue eosinophils.

Reslizumab is indicated as an add-on treatment in adult patients with severe eosinophilic asthma.

Table I: Reslizumab chemical information and naming
Property Reslizumab
CAS number 241473-69-8
Molecular weight 147 kDa
Australian Biological Name (ABN) Reslizumab
Other names Immuoglobulin G4; anti-(human interleukin 5) (human-rat monoclonal SCH 55700 γ4-chain); disulphide with human-rat monoclonal SCH 55700 light chain dimer

Scheduling status

Reslizumab is not specifically scheduled but is captured by the Schedule 4 class entry for monoclonal antibodies 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

MONOCLONAL ANTIBODIES for therapeutic us except:

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

International regulations

Reslizumab is not classified in New Zealand. Reslizumab is classified as a prescription only medicine in the United States of America and the European Union. In Canada, reslizumab is classified as a prescription medicine and is also in Schedule D (drugs listed in Schedule D of the Food and Drugs Act, i.e. biological products).

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 reslizumab 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

RESLIZUMAB.

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 (e) the potential for abuse.

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

  • Reslizumab is an NCE with no clinical or marketing experience in Australia, but shares some similarities with the currently marketed medicine mepolizumab.
  • Reslizumab is for severe eosinophilic asthma in patients inadequately controlled on maximum dose ICS and another preventative medicine. It is likely to be prescribed only by specialist physicians.
  • The potential for abuse of reslizumab is unlikely.

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