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Final decisions and reasons for NCEs, medicines and chemicals, November 2018

Scheduling medicines and poisons

26 April 2019

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4.1. Galcanezumab

Part B - Final decisions on matters not referred to an expert advisory committee

4. New Chemical Entities - medicines for human therapeutic use

4.1. Galcanezumab

Note

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Delegate's final decision
Final decision

The delegate's final decision is to amend the Poisons Standard to include galcanezumab in Schedule 4 as follows:

Schedule 4 - New Entry

GALCANEZUMAB

Index - New Entry

GALCANEZUMAB

Schedule 4

Implementation date

1 June 2019

Reasons

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate for the decision include:

  1. the risks and benefits of the use of a substance:

    It is a new chemical entity with no clinical or marketing experience in Australia.

  2. the purposes for which a substance is to be used and the extent of use of a substance:

    Migraine prophylaxis requires medical assessment and monitoring.

  3. the toxicity of a substance:

    Potential toxicity is not known.

  4. the dosage, formulation, labelling, packaging and presentation of a substance:

    Substance requires subcutaneous injection

  5. the potential for abuse of a substance:

    Nil

  6. any other matters that the Secretary considers necessary to protect public health:

    Nil

Scheduling proposal

The delegate of the Secretary proposed to amend the Poisons Standard with respect to galcanezumab, a new chemical entity (NCE) for a human therapeutic medicine.

Scheduling status

Galcanezumab is not specifically scheduled in the Poisons Standard but as it is a monoclonal antibody, galcanezumab is captured by the Schedule 4 entry for monoclonal antibodies as follows:

Schedule 4

MONOCLONAL ANTIBODIES for therapeutic use except:

  1. in diagnostic test kits; or
  2. when separately specified in these Schedules.
Delegate's considerations
  • Section 52E(1) of the Therapeutic Goods Act 1989;
  • Scheduling Policy Framework (SPF 2018); and
  • Advice on the place in therapy of this NCE.

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