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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 romosozumab 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:
- Romosozumab is a humanised monoclonal antibody that binds to and inhibits sclerostin
- Treatment with romosozumab increases bone density and prevents fractures in patients with osteoporosis
- Risks of treatment include hypocalcaemia (prevented by monitoring and concomitant use of calcium and vitamin D), osteonecrosis of the jaw
- the purposes for which a substance is to be used and the extent of use of a substance:
- Romosozumab is to be used in the treatment of men and women with osteoporosis.
- The diagnosis of osteoporosis requires an assessment by a medical officer. It is based on clinical history and examination, as well as diagnostic tests.
- the toxicity of a substance:
- No concerning toxicity was identified in animal studies. Pregnancy category B3
- the dosage, formulation, labelling, packaging and presentation of a substance:
- Romosozumab is administered as a subcutaneous injection. The formulation contains 105mg/1.17ml. The dosage is 210mg each month for 12 months
- the potential for abuse of a substance:
- any other matters that the Secretary considers necessary to protect public health:
Applicant's scheduling proposal and reasons for proposal
The delegate of the Secretary proposed to amend the Poisons Standard with respect to romosozumab.
Current scheduling status
Romosozumab 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;
- The TGA clinical evaluation report;
- Delegate's overview;
- ACM advice.