1.10. Ferric derisomaltose
Scheduling proposal
The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of ferric derisomaltose, a new chemical entity (NCE) for a human therapeutic medicine.
Substance summary
Ferric derisomaltose is a colloid (intended to be intravenously injected or infused) with bound iron in spheroidal iron-carbohydrate particles. This complex enables release of bioavailable iron to iron-binding proteins.
Ferric derisomaltose is indicated for the treatment of iron deficiency in adults, under the following conditions:
- when oral preparations are ineffective or cannot be used; and
- when there is a clinical need to deliver iron rapidly.
The diagnosis must be based on laboratory tests.
| Property | Ferric derisomaltose |
|---|---|
| CAS number | 1345510-43-1 |
| Chemical structure |  |
| Molecular formula | (C6H11O5)(C6H10O5)n(C6H13O5).FeIIIcomplex (n = 4.2) |
| Molecular weight | 562.3 g/mol |
| Chemical names | Iron (III) hydroxide isomaltoside 1000; (1⟶6)-α-D-glucopyranan-(1⟶6)-α-D-glucitol iron(III) complex |
| Other names | Ferric derisomaltose (ANN and INN); iron isomaltoside, iron isomaltooligosaccharide, iron oligosaccharide, iron isomaltopentaoside 100 |
Scheduling status
Ferric derisomaltose is not specifically scheduled and is not captured by any entry 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)).
International regulations
Ferric derisomaltose is unclassified in New Zealand, the United States of America, Canada and Europe. In the United Kingdom, ferric derisomaltose is a prescription only medicine.
Delegate’s consideration
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:
- 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;
- The new drug application; and
- Other.
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 ferric derisomaltose 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
FERRIC DERISOMALTOSE.
The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989are: (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; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse; and (f) any other matters that the Secretary considers necessary to protect public health.
The delegate decided that the reasons for the final decision comprise the following:
- Ferric derisomaltose is an NCE with no marketing experience in Australia.
- The risks and benefits of use have been considered in the evaluation for product registration.
- All matters under subsections 52E(1) have been considered as part of the evaluation and approval process.