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Posted 15 January 2025 AM
An update to the TGA's review list shows an extra eight drug submissions were accepted for evaluation before the close of 2024.
The list last updated in December now includes two new products - Accelagen's antibacterial Fetroja for infections caused by aerobic Gram-negative organisms in adults with limited treatment options and AA-Med's Efesa for anaemia in non-dialysis chronic kidney disease.
Efesa is a novel long-acting erythropoietin treatment jointly developed by Korean biotech firm Genexine and Kalbe in Indonesia. Compared to first-generation anaemia treatments, which are dose every two or three days, Efesa offers dosing every two to four weeks.
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The remaining submissions added to the review list cover six label expansion requests.
At the front of the que is Novartis' Scemblix, which was accepted for evaluation under priority review for adults with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in the chronic phase.
'Chronic phase' refers to the initial stage of the disease and it appears that the company is seeking use of Scemblix as a first line treatment. Scemblix is currently registered for patients with Ph+ CML in the chronic phase who have previously been treated with two or more tyrosine kinase inhibitors.
Novartis has another submission for its blockbuster spinal muscular atrophy (SMA) gene therapy Zolgensma. Although the exact indication is unclear, it appears that the company is seeking to make the drug available for an older patient population with alterations in the SMN1 gene.
The company recently touted a Phase 3 trial win for intrathecal Zolgensma in children and young adults with SMA. Zogensma as an intravenous infusion has been approved in Australia for children under two years with SMA since 2021.
The TGA is also reviewing the AstraZeneca and Daiichi Sanky-partnered antibody drug-conjugate Enhertu for the treatment of adults with HER2-low or HER2-ultralow breast cancer that cannot be removed by surgery or has spread to other parts of the body. The treatment is intended for patients who have already tried at least one hormone therapy on their metastatic cancer.
Another oncology expansion on the cards covers Bayer's Nubeqa for the treatment of patients with metastatic hormone-sensitive prostate cancer (cancer that has spread from the prostate to other parts of the body but is still sensitive to treatment).
Rounding up the list is Boehringer Ingelheim's Spevigo to treat and prevent flares of generalised pustular psoriasis in adults and adolescents aged 12 and older plus AstraZeneca's Flumist for the prevention of influenza in individuals two years to 49 years of age.
Tiffany Walker
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