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Scheduling delegate's final decisions, October 2017
Scheduling of medicines and poisons
The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of teduglutide, a new chemical entity (NCE) for a human therapeutic medicine.
Teduglutide is an analog of a naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine. Similar to GLP-2, teduglutide is 33 amino acids in length with an amino acid substitution of alanine by glycine at the second position of the N-terminus. The single amino acid substitution relative to naturally occurring GLP-2 results in resistance to in vivo degradation by the enzyme dipeptidyl peptidase-IV (DPP-IV), resulting in an extended half-life. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, vasoactive intestinal polypeptide (VIP), nitric oxide and keratinocyte growth factor (KGF).
Teduglutide is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parental support.
ABN – Teduglutide
Teduglutide is not specifically scheduled and is not captured by any entry in the current Poisons Standard.
Teduglutide is not classified in New Zealand.
Teduglutide is a prescription medicine in Canada and the USA.
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 new drug application; and
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 Teduglutide in Schedule 4, with an implementation date of 1 October 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; (b) the purpose and the extent of use 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:
- Teduglutide is a new chemical entity with no clinical experience in Australia.
- Teduglutide requires medical supervision by a practitioner experienced in the management of short bowel syndrome for safe use.
- Teduglutide is intended for subcutaneous injection; training of patient will be required.
- The potential for abuse of Teduglutide is unlikely.