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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:
- the risks and benefits of the use of a substance
- Benralizumab is a new chemical entity with no clinical or marketing experience in Australia.
- 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.
- the toxicity of a substance
- Adverse events are not dose related. The main treatment emergent adverse events are hypersensitivity reactions, these are uncommon.
- 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.
- the potential for abuse of a substance
- There is a low potential for abuse.
- 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.
| 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:
- in diagnostic test kits; or
- 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.