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Scheduling delegate's final decisions, March 2017

23 March 2017

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1.1 Albutrepenonacog alfa

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

New Chemical Entities – medicines for human therapeutic use

1.1 Albutrepenonacog alfa

Scheduling proposal

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

Substance summary

Albutrepenonacog alfa is a recombinant form of coagulation factor IX (FIX) genetically fused to human albumin to prolong clotting activity and is indicated for IV use in adults and children with haemophilia B to control and prevent bleeding episodes.

Nomenclature: Albutrepenonacog alfa (ABN and INN).

Scheduling status

Albutrepenonacog alfa is currently exempt from scheduling because it is captured under the Appendix A entry for HUMAN BLOOD PRODUCTS under item (c)(iv) clotting factors in the current Poisons Standard:

Appendix A - General exemptions

HUMAN BLOOD PRODUCTS including:

  1. whole blood;
  2. blood components including red cells, white cells, platelets and plasma (including cryoprecipitate); and
  3. the following plasma-derived therapeutic proteins; and their equivalent recombinant alternatives:
    1. albumin;
    2. anticoagulation complex;
    3. C1 esterase inhibitors;
    4. clotting factors;
    5. fibrinogen;
    6. protein C;
    7. prothrombin complex concentrate (PCC) ; and
    8. thrombin.
International regulations

Albutrepenonacog alfa is classified as a Schedule D (biological) drug in Canada and is a prescription only medicine in the EU and the USA. Albutrepenonacog alfa is not classified in New Zealand.

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 Appendix A.

Delegate's final decision

The delegate has made a final decision that albutrepenonacog alfa is exempt from scheduling as it falls under the Appendix A entry for human blood products in the Poisons Standard.

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 (d) the dosage, formulation, labelling, packaging and presentation of a substance.

The reasons for the final decision comprise the following:

  • Albutrepenonacog alfa is a recombinant form of a plasma-derived therapeutic clotting protein and is therefore captured by the Appendix A entry for human blood products.
  • Albutrepenonacog alfa is an NCE with no marketing experience in Australia. Expected benefits are control of bleeding episodes in patients with haemophilia B, risks are as for other recombinant products in this class, including hypersensitivity.
  • Albutrepenonacog alfa is used by a defined patient population under the supervision of a physician experienced in the treatment of haemophilia B. Monitoring is routine in management of the disorder.
  • The potential for abuse of albutrepenonacog alfa is unlikely.

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