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Final scheduling decisions and reasons: NCEs and Appendix H
Part A - Final decisions on matters not referred to an expert advisory committee
2. New Chemical Entities - medicines for human therapeutic use
Delegate's final decision
The delegate's final decision is to amend the Poisons Standard to include lanadelumab in Schedule 4 as follows:
Schedule 4 - New Entry
Index - New Entry
Proposed implementation date:
1 February 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 and marketing experience in Australia.
- the purposes for which a substance is to be used and the extent of use of a substance:
It is to be used for routine prevention of attacks of hereditary angioedema (HAE) in patients aged 12 years and older
- the toxicity of a substance:
It can cause adverse events, such as hypersensitivity, injection site reactions, etc.
- the dosage, formulation, labelling, packaging and presentation of a substance:
It is administered by subcutaneous injection
- the potential for abuse of a substance:
Unlikely to be abused
- any other matters that the Secretary considers necessary to protect public health:
Correct diagnosis of hereditary angioedema by a medical specialist is required prior to prescribing this product
Applicant's scheduling proposal and reasons for proposal
The delegate of the Secretary proposed to amend the Poisons Standard with respect to lanadelumab.
Current scheduling status
Lanadelumab is not specifically scheduled in the Poisons Standard, but as it is composed of a monoclonal antibody, it 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.
The delegate considered the following in regards to this scheduling:
- Subsection 52E(1) of the Therapeutic Goods Act 1989;
- The Scheduling Policy Framework (2018) scheduling factors;
- Advice on the place in therapy of this NCE.