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Section A: Premarket registration applications
At this meeting, the Committee provided advice on 3 applications under evaluation by the TGA, as below.
The dates of commencement of the evaluation of these applications are available at Prescription medicines: applications under evaluation, see: Prescription medicines: Applications under evaluation.
Further details of the ACM discussion and advice associated with these items may be released within the Australian Public Assessment Reports (AusPARs). To browse all AusPARs see: Australian Public Assessment Reports (AusPAR).
Section B: Post-market items
Human normal immunoglobulin (PRIVIGEN AU) and increased rates of adverse event (AE) reporting
Intravenous immunoglobulin (IVIg) is a blood product used in immunomodulatory therapies, and to treat immunodeficiency in both adult and paediatric patients. PRIVIGEN AU is an IVIg product first marketed for use in Australia in April 2023 replacing another IVIg product, INTRAGAM 10. PRIVIGEN AU is a human normal immunoglobulin product composed mainly of immunoglobulin G (IgG) from Australian plasma donors and is distinct from another registered IVIg product, PRIVIGEN, which is made from internationally sourced plasma.
In 2024, the Therapeutic Goods Administration (TGA) received a safety signal indicating a higher rate of adverse events were being reported in patients treated with PRIVIGEN AU, compared to other IVIg products. Of particular note was the increased reported rate of aseptic meningitis syndrome (AMS) which is a known side effect of IVIg products.
In October 2024, the ACM was asked to provide advice on whether they considered there to be evidence of an increased rate of adverse events beyond what was expected for a new IVIg product, and what the clinical significance was. The ACM advised that, at that time, there was insufficient evidence to support the conclusion that there is an increased rate of adverse events associated with PRIVIGEN AU as compared to PRIVIGEN and INTRAGAM 10. However, the ACM advised that ongoing monitoring was warranted to clarify whether the rise in adverse event reporting rates was associated with a true safety signal or if it could be attributed to a first dose effect or reporting bias. A more detailed summary of this advice is available from the available ACM meeting statement, Meeting 47, 3 and 4 October 2024.
In April 2026, the ACM was asked to consider historical and newly available data from follow-up analyses to advise on whether the ongoing sustained increased reporting rate of AEs for PRIVIGEN AU in comparison to PRIVIGEN and INTRAGAM 10 warranted TGA regulatory action.
Overall, the ACM acknowledged that the available data supported a persistent increased rate of adverse event reporting associated with PRIVIGEN AU as compared to INTRAGAM 10 and PRIVIGEN at similar times from market entry. The ACM supported collaborative efforts in the ongoing monitoring of this signal, including work to strengthen existing monitoring systems to improve overall data clarity.
However, the ACM did not advise that additional TGA regulatory action was warranted at that time because the available data remained insufficient to accurately determine key contributing factors.
Further information
For further information on the Advisory Committee on Medicines, please visit: Advisory Committee on Medicines (ACM) or contact the ACM Secretary by email: ACM@health.gov.au.