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Scheduling delegate's final decisions: December 2013

Scheduling medicines and poisons

19 December 2013

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Final decisions on matters not referred to an expert advisory committee

1. New chemical entities - medicines for human therapeutic use

1.1 Lurasidone

Scheduling proposal

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

Lurasidone is an atypical antipsychotic agent.

Lurasidone is indicated for treatment of schizophrenia.

The delegate decided to make a delegate-only decision for the substance. The Advisory Committee on Medicines Scheduling (ACMS) was consulted on the requirement for a sedation warning. The delegate has considered the committee's recommendation and lurasidone is to be included in Appendix K (see Final Decisions on Matters referred to the ACMS #9 http://www.tga.gov.au/industry/scheduling-decision...).

Scheduling status

Lurasidone is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons.

Lurasidone is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application for scheduling.

  • The new drug application.
  • The TGA evaluation report.
  • The advice of the Advisory Committee on Prescription Medicines.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.
Delegates' final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include lurasidone in Schedule 4, with an implementation date of 1 Feb 2014.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) risks and benefits; (b) purpose and the extent of use 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 of the following.

  • Lurasidone is a new chemical entity with no clinical/marketing experience in Australia.
  • It is a treatment for schizophrenia, a condition requiring medical diagnosis and management.
  • This substance has similar side-effects to other atypical antipsychotic agents and should have similar scheduling requirements.
Schedule 4 - New entry

LURASIDONE.

1.2 Vedolizumab

Scheduling proposal

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

Vedolizumab is immunoglobulin G1-kappa, anti-[Homo sapiens alpha4beta7 integrin (lymphocyte Peyer's patch adhesion molecule 1, LPAM-1), humanized monoclonal antibody.

Vedolizumab is indicated for treatment of

  • adult patients with moderate to severe ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.
  • adult patients with moderate to severe Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

Vedolizumab is not specifically scheduled in the Standard for the Uniform Scheduling of Medicines and Poisons but may be captured by a group/class entry for monoclonal antibodies:

SCHEDULE 4

MONOCLONAL ANTIBODIES for therapeutic use except:

  1. in diagnostic test kits; or
  2. when separately specified in these Schedules.

Vedolizumab is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application for scheduling.

  • The new drug application.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

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 Standard for the Uniform Scheduling of Medicines and Poisons to include vedolizumab in Schedule 4, with an implementation date of 1 Feb 2014.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) risks and benefits; (b) purpose and the extent of use and (c) toxicity, d) dosage, formulation, labelling, packaging and presentation, and (e) the potential for abuse of vedolizumab.

The delegate decided that the reasons for the final decision comprise of the following.

  • Vedolizumab is a new chemical entity with no clinical and marketing experience in Australia.
  • Vedolizumab is intended for the treatment of life-threatening conditions.
  • Vedolizumab has side effects that also require close monitoring.
Schedule 4 - New entry

VEDOLIZUMAB.

1.3 Vortioxetine

Scheduling proposal

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

Vortioxetine is an antidepressant with a novel mechanism of action that belongs to a group of selective serotonine reuptake inhibitors (SSRIs).

Vortioxetine is indicated for the treatment of major depressive disorder including prevention of relapse.

The delegate decided to make a delegate-only decision on the scheduling of the substance. The Advisory Committee on Medicines Scheduling (ACMS) were consulted on recommendation of inclusion in Appendix L. The ACMS recommendation was not to include vortioxetine in Appendix L (see Final Decisions on Matters referred to the ACMS #9 http://www.tga.gov.au/industry/scheduling-decision...).

Scheduling status

Vortioxetine is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons.

Vortioxetine is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application for scheduling.

  • The new drug application.
  • The TGA evaluation report.
  • The advice of the Advisory Committee on Prescription Medicines.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.

Delegates' final decision.

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include VORTIOXETINE in Schedule 4, with an implementation date of 1 Feb 2014.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) risks and benefits; (b) purpose and the extent of use and (c) toxicity, d) dosage, formulation, labelling, packaging and presentation, and (e) the potential for abuse of vortioxetine.

The delegate decided that the reasons for the final decision comprise of the following.

  • Vortioxetine is a new chemical entity with no clinical/marketing experience in Australia.
  • Vortioxetine affects multiple CNS receptors, particularly serotonin receptors. Other antidepressants acting at serotonin receptors (e.g. SSRIs) have been associated with pulmonary hypertension and with withdrawal syndrome in newborns.
  • Vortioxetine is an antidepressant with a novel mechanism of action, inhibiting serotonin transport and direct agonist action on serotonin receptors. It also has effects on many other CNS receptors.
  • The toxicity of vortioxetine is similar to that of other already scheduled SSRIs.
  • 5, 10, 15 and 20 mg film coated tablets.
  • The potential for abuse of this substance is limited.
Schedule 4 - New entry

VORTIOXETINE.

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