You are here

Scheduling delegate's final decisions, October 2017

Scheduling of medicines and poisons

31 October 2017

Book pagination

6.2 Guselkumab

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of guselkumab, a new chemical entity (NCE) for a human therapeutic medicine.

Substance summary

Guselkumab is a fully human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody (mAb) that binds selectively to the extracellular human interleukin 23 (IL-23) protein with high specificity and affinity. Guselkumab is produced in a mammalian cell line using recombinant DNA technology.

JANSSEN GUSELKUMAB is indicated for the treatment of moderate to severe plaque psoriasis, scalp, nail, and hand and foot psoriasis and improvement of health related quality of life in adult patients who are candidates for systemic therapy or phototherapy.

Table 6.2a: Identifiers, properties and naming of Guselkumab
Property Guselkumab
CAS Number 1350289-85-8
Chemical structure chemical structure of vinyl acetate
Molecular formula C6402H9864N1676O1994S42
Molecular weight 143.6 kg/mol
ANN/INN

eBS ID: 111307

INN: Guselkumab

Scheduling status

Guselkumab is not specifically scheduled, but as it is a monoclonal antibody, guselkumab is captured by group entry under Schedule 4. However, the delegate has decided to specifically list guselkumab in Schedule 4.

International regulations

Guselkumab is unclassified in New Zealand, Canada and USA.

Delegate’s considerations

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;
  • 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 guselkumab 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

GUSELKUMAB.

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 (e) the potential for abuse.

The delegate decided that the reasons for the final decision comprise the following:

  • Guselkumab is a new chemical entity with no clinical/marketing experience in Australia;
  • Guselkumab should have a similar risk/benefit profile to other monoclonal antibodies already marketed in Australia;
  • Guselkumab is used to manage psoriasis; and
  • The potential for abuse of guselkumab is unlikely.

Book pagination