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Scheduling delegate's final decisions, June 2017

Scheduling medicines and poisons

29 June 2017

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4.5 Bezlotoxumab

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

New Chemical Entities – medicines for human therapeutic use

4.5 Bezlotoxumab

Scheduling proposal

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

Substance summary

Bezlotoxumab is a specific fully human monoclonal antibody that binds with high affinity to C. difficile toxin B. Bezlotoxumab is an IgG1 immunoglobulin, produced in Chinese hamster ovary cells by recombinant DNA technology.

Bezlotoxumab is indicated for the prevention of Clostridium difficile infection (CDI) recurrence in patients 18 years or older receiving antibiotic therapy for CDI.

Table 4.5: Identifiers, properties and naming of Bezlotoxumab
Property Bezlotoxumab
CAS Number 1246264-45-8
Molecular formula C6464H9974N1726O2014S46
Molecular weight 148.2 kDa
ANN/INN eBS ID: 110777
Other: eBS ID: 110777
ATC code: J06BB21
Scheduling status

Bezlotoxumab 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

Bezlotoxumab is a Prescription Medicine in the USA but not classified in New Zealand or Canada.

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 bezlotoxumab 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

BEZLOTOXUMAB.

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 (d) the dosage, formulation, labelling, packaging and presentation of a substance.

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

  • Bezlotoxumab is an NCE with no clinical/marketing experience in Australia
  • Bezlotoxumab should be prescribed by medical professionals who are familiar with the diagnosis and management of Clostridium difficile infection.
  • The most common adverse reactions following treatment with Bezlotoxumab are nausea, diarrhoea, pyrexia and headache.
  • Bezlotoxumab is a pregnancy Category B2 drug.
  • The potential for abuse of bezlotoxumab is unlikely.

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