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Final decisions amending, or not amending, the current Poisons Standard, April 2018

Scheduling medicines and poisons

10 April 2018

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5.3 Benralizumab

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

5. New Chemical Entities - medicines for human therapeutic use

5.3 Benralizumab

Delegate's final decision
Final decision:

The delegate has made a final decision to create a new Schedule 4 entry for benralizumab in the Poisons Standard as follows:

Schedule 4 - New Entry

BENRALIZUMAB.

Implementation date: 1 June 2018
Reasons:

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate include:

  1. the risks and benefits of the use of a substance
    • Benralizumab is a new chemical entity with no clinical or marketing experience in Australia.
  2. the purposes for which a substance is to be used and the extent of use of a substance
    • There are other monoclonal antibodies selective for the IL-5 receptor used to treat eosinophilic asthma.
    • The proposed indication for benralizumab is for add-on maintenance treatment for severe asthma in patients with an eosinophilic phenotype. It is likely to be prescribed mainly by respiratory specialists.
  3. the toxicity of a substance
    • Adverse events are not dose related. The main treatment emergent adverse events are hypersensitivity reactions, these are uncommon.
  4. the dosage, formulation, labelling, packaging and presentation of a substance
    • The recommended dose is 30 mg of benralizumab given by subcutaneous injection every 4 weeks for 3 doses then every 8 weeks.
    • Each pack contains a single dose, single use, sterile pre-filled syringe.
  5. the potential for abuse of a substance
    • There is a low potential for abuse.
  6. any other matters that the Secretary considers necessary to protect public health
    • Nil.
Scheduling proposal

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

Substance summary

Benralizumab is a humanised, afucosylated, monoclonal antibody selective for the alpha subunit of the human interleukin-5 receptor (IL-5Rα). Benralizumab is of the IgG1, kappa-class produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.

Benralizumab is indicated as an add-on maintenance treatment for severe asthma in patients with an eosinophilic phenotype.

Table 5.3.1: Identifiers, properties and naming of benralizumab
Property Benralizumab
CAS Number 1044511-01-4
Molecular formula C6492H10060N1724O2028S42
Molecular weight 146.0 kg/mol
ANN/INN

eBS ID: 111153

INN: Benralizumab

Scheduling status

Benralizumab is not specifically scheduled 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 March 2018 (SUSMP No. 20)), but as a monoclonal antibody, it is captured by the Schedule 4 entry for monoclonal antibodies as follows:

Schedule 4

MONOCLONAL ANTIBODIES for therapeutic use except:

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

Benralizumab is unclassified in New Zealand, Canada and USA.

Delegate’s considerations

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 scheduling factors; 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.

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