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Scheduling delegate's final decisions, January 2017
Scheduling medicines and poisons
Final decisions on matters not referred to an expert advisory committee
2. New Chemical Entities – medicines for human therapeutic use
The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of sonidegib diphosphate, a new chemical entity (NCE) for a human therapeutic medicine.
Sonidegib diphosphate is a potent, selective, and orally bioavailable smoothened (Smo) antagonist. Smoothened is a transmembrane G protein-coupled receptor-like molecule that positively regulates the Hedgehog (Hh) signal transduction pathway.
Sonidegib diphosphate is indicated for the treatment of adult patients with:
- Locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.
- Metastatic BCC.
AAN – Sonidegib diphosphate
Sonidegib diphosphate is not specifically scheduled and is not captured by any entry in the current Poisons Standard.
Sonidegib diphosphate is not classified in New Zealand.
The delegate made a delegate-only decision; hence 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;
- The advice of the Advisory Committee on Prescription Medicines; 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 sonidegib in Schedule 4, with an implementation date of 1 February 2017.
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.
The delegate decided that the reasons for the final decision comprise the following:
- It is a NCE with no clinical experience in Australia;
- Sonidegib is Pregnancy Category X (as is the first in class Vismodegib) but its use is in a restricted population and likely to be under close supervision of appropriately specialized physicians, therefore label warnings are not considered necessary at this stage; and
- The potential for abuse of sonidegib is unlikely.