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Part B - Final decisions on matters not referred to an expert advisory committee
4. New Chemical Entities - medicines for human therapeutic use
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Delegate's final decision
The delegate's final decision is to amend the Poisons Standard to include galcanezumab in Schedule 4 as follows:
Schedule 4 - New Entry
Index - New Entry
1 June 2019
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate for the decision include:
- the risks and benefits of the use of a substance:
It 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:
Migraine prophylaxis requires medical assessment and monitoring.
- the toxicity of a substance:
Potential toxicity is not known.
- the dosage, formulation, labelling, packaging and presentation of a substance:
Substance requires subcutaneous injection
- the potential for abuse of a substance:
- any other matters that the Secretary considers necessary to protect public health:
The delegate of the Secretary proposed to amend the Poisons Standard with respect to galcanezumab, a new chemical entity (NCE) for a human therapeutic medicine.
Galcanezumab is not specifically scheduled in the Poisons Standard but as it is a monoclonal antibody, galcanezumab is captured by the Schedule 4 entry for monoclonal antibodies as follows:
MONOCLONAL ANTIBODIES for therapeutic use except:
- in diagnostic test kits; or
- when separately specified in these Schedules.
- Section 52E(1) of the Therapeutic Goods Act 1989;
- Scheduling Policy Framework (SPF 2018); and
- Advice on the place in therapy of this NCE.