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Scheduling delegate's final decisions, January 2018
Scheduling medicines and poisons
The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of erenumab, a new chemical (biological) entity (NCE) for a human therapeutic medicine.
Erenumab is a human immunoglobulin G2 (IgG2) monoclonal antibody that has high affinity binding to the calcitonin gene-related peptide (CGRP) receptor. CGRP is a neuropeptide that modulates nociceptive signalling and a vasodilator that has been associated with migraine pathophysiology.
Erenumab is indicated for the prophylaxis of migraine in adults.
Erenumab is not specifically scheduled but is captured by the Schedule 4 class entry for monoclonal antibodies 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 October 2017 (SUSMP No. 18)) as follows:
MONOCLONAL ANTIBODIES for therapeutic us except:
- in diagnostic test kits; or
- when separately specified in these Schedules.
Erenumab does not appear to be classified internationally.
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 erenumab in Schedule 4 with an implementation date of 1 February 2018.
The delegate has decided that the wording for the schedule entry will be as follows:
Schedule 4 – New Entry
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:
- the risks and benefits of the use of a substance
- Erenumab is an NCE with no clinical or marketing experience in Australia.
- Migraine prophylaxis requires medical assessment and monitoring.
- Potential toxicity is not known.
- Erenumab requires subcutaneous injection.