International work-sharing - First medicines approved by all five Access Consortium regulators

The Therapeutic Goods Administration has approved two new medicines as part of the Access New Active-Substance Work-Sharing Initiative (NASWSI):

• Asciminib (Scemblix®) was approved on 14 July 2022 after 171 working days of TGA evaluation.

Asciminib is indicated for the treatment of patients 18 years of age and above with:

• Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors;
• Ph+ CML in CP with the T315I mutation.

Asciminib has a novel mechanism of action in the treatment of chronic myeloid leukaemia, and is active in cases with a T315I mutation. Chronic myeloid leukaemia with a T315I mutation is resistant to most current treatments.

• Faricimab (Vabysmo®) was approved on 4 August 2022 after 179 days of TGA evaluation.

Faricimab is indicated for the treatment of:

• Neovascular (wet) age-related macular degeneration (nAMD);
• Diabetic macular oedema (DMO).

Vabysmo (faricimab) is a bispecific angiopoietin-2 (Ang-2) and vascular endothelial growth factor (VEGF) inhibitor and targeting both of these factors provides a clinically relevant benefit to patients with nAMD or DMO.

These were the first applications jointly evaluated by all five Access Consortium members - the TGA, Health Canada, Health Sciences Authority (HSA) Singapore, Swissmedic and the Medicines and Healthcare products Regulatory Authority (MHRA) of the United Kingdom, and are the twenty-second and twenty-third medicines approved through the NASWSI since it commenced in 2018.

The Access Consortium is an alliance of like-minded regulatory authorities, whose goal is to maximise international cooperation, reduce duplication, and increase each agency's capacity to ensure consumers have timely access to high quality, safe and effective therapeutic products.

The Access work-sharing initiatives streamline the medicine registration process and reduce duplication of evaluation effort, with each participating agency leading the evaluation of a different part of the submission dossier. However, each agency makes an independent decision regarding approval (market authorisation) of the new medicine.

Further information on the Access Consortium and the New Active Substance Work-Sharing Initiative can be found on the TGA website.