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Part B - Final decisions on matters not referred to an expert advisory committee
4. New Chemical Entities - medicines for human therapeutic use
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Delegate's final decision
The delegate's final decision is to amend the Poisons Standard to include cenegermin in Schedule 4 as follows:
Schedule 4 - New Entry
Index - New Entry
1 June 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:
Cenegermin is a new biological medicine not currently captured under an existing schedule.
In clinical trials, treatment with cenegermin resulted in healing of corneal epithelial defects, improvement of corneal sensation, and improvement in vision. There were no major adverse effects.
- the purposes for which a substance is to be used and the extent of use of a substance:
Cenegermin is indicated for the treatment of neurotrophic keratitis.
The diagnosis of neurotrophic keratitis requires a detailed clinical assessment and ongoing assessment by an ophthalmologist. This is a prescription medicine.
- the toxicity of a substance:
Clinical trials did not show any evidence of toxicity when used as directed in the clinical trial protocol.
- the dosage, formulation, labelling, packaging and presentation of a substance:
Eye drop. given as 1 drop 6 times a day
- the potential for abuse of a substance:
- any other matters that the Secretary considers necessary to protect public health:
The delegate of the Secretary proposed to amend the Poisons Standard with respect to cenegermin, a new chemical entity (NCE) for a human therapeutic medicine.
Cenegermin is not specifically scheduled and is not captured by any entry in the Poisons Standard.
- Advice on the place in therapy of this NCE;
- Scheduling Policy Framework (SPF 2018); and
- Section 52E(1) of the Therapeutic Goods Act 1989.