Section A: Premarket registration applications
At this meeting, the committee provided advice on 11 applications under evaluation by the TGA, as below.
| Active ingredient (TRADE NAME) | Sponsor | Therapeutic area | Application designations |
|---|---|---|---|
| Applications for a 'new medicine' containing a new active substance (new chemical entity or new biological entity) not currently or previously approved in Australia (Application Type A) | |||
| Ustekinumab (STEQEYMA) | Celltrion Healthcare Australia Pty Ltd | Plaque Psoriasis Psoriatic Arthritis Crohn’s Disease Ulcerative Colitis | |
| Vorasidenib (VORANIGO) | Servier Laboratories Australia Pty Ltd | Non-Enhancing Astrocytoma Oligodendroma | Orphan Priority |
| Natalizumab (TYRUKO) | Sandoz Pty Ltd | Multiple Sclerosis | |
| Fruquintinib (FRUZAQLA) | Takeda Pharmaceuticals Australia Pty Ltd | Colorectal Cancer | |
| Lecanemab (LEQEMBI) | Eisai Australia Pty Ltd | Alzheimer’s Dementia | |
| Applications for a 'new combination', where two or more already approved medicines are combined into a single product (Application Type B) | |||
| Macitentan, Tadalafil (OPSYNVI) | Janssen-Cilag Pty Ltd | Pulmonary Arterial Hypertension | |
| Applications for a 'new indication', or additional therapeutic use, for an already approved medicine (Application Type C) | |||
| Osimertinib Mesilate (TAGRISSO) | AstraZeneca Pty Ltd | Lung Cancer | |
| Brexpiprazole (REXULTI) | Lundbeck Australia Pty Ltd | Alzheimer’s Dementia | |
| Tirzepatide (MOUNJARO) | Eli Lilly Australia Pty Ltd | Chronic Weight Management | |
| Faricimab (VABYSMO) | Roche Products Pty Ltd | Macular Oedema | |
The dates of commencement of the evaluation of these applications are available at Prescription medicines: applications under evaluation.
The committee also provided advice on:
- 1 application for transition from provisional approval to full registration (Application Type S)
Further details of the ACM discussion and advice associated with these items may be released within the Australian Public Assessment Reports (AusPARs).
Section B: Post-market items
Mountelukast and Neuropsychiatric Events
Montelukast is a medicine prescribed for asthma or allergic rhinitis.
The origin of this signal investigation was notification by the TGA’s international regulatory counterparts that their existing warnings about neuropsychiatric effects in montelukast product information documents will be strengthened. In addition, the TGA has been approached by consumer advocacy groups who have informed the TGA that in their view patients and prescribers are not adequately aware of the risks.
Montelukast and associated neuropsychiatric events were considered by the ACM in their 8th meeting, in April 2018. A safety alert on this issue was published by the TGA in July 2018.
At the 46th meeting, the ACM advised that the term ‘neuropsychiatric events’ encompasses too wide a range of symptoms and presentations to be meaningful and confuses symptoms with diagnosis. However, the ACM acknowledged that this term is used by international regulators. The ACM was asked to provide advice on the TGA’s current risk mitigation strategies for Montelukast and how these related to that of international regulatory counterparts. Specifically, the ACM was asked to advise whether a boxed warning should be added to the Australian PI regarding the association with neuropsychiatric adverse events.
The ACM advised that a 2024 review of the evidence did not identify any new neuropsychiatric risks associated with montelukast. The existing evidence for the potential association between montelukast and neuropsychiatric risks is uncertain, and has not changed.
However, on balance, the ACM advised that while the scientific and clinical evidence to 2024 does not demonstrate a causal association between montelukast and neuropsychiatric symptoms, alignment with international regulators in this case and in acknowledgment of consumer concerns, it would now be appropriate to implement a boxed warning.
In formulating the boxed warning, the ACM supported careful wording that neuropsychiatric events (with examples) are generally mild and may be coincidental.
The ACM also recommended additional changes to the Australian PI to add wording around discontinuation of montelukast if neuropsychiatric symptoms emerge, in line with wording found in the Canadian monograph.
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.