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Section A: Premarket registration applications
At this meeting, the committee provided advice on 7 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.
The committee also provided advice on:
- 2 applications for major variations (new dosage form, change/increase in patient group, change in dosage, new strength, new route of administration) (Application Type F).
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
Denosumab (PROLIA) and multiple vertebral fractures following discontinuation or delay
In Australia, osteoporosis affects approximately 3.4% of the population. The condition is significantly more prevalent among women aged 75 and over. Denosumab (PROLIA) is used widely as a 6 monthly injection to inhibit bone resorption and to improve Bone Mineral Density (BMD) in patients with osteoporosis. PROLIA’s effects of inhibiting bone resorption and improving BMD are rapidly reversed when the medication is stopped.
Multiple vertebral fractures (MVF) following delay or discontinuation of PROLIA is a known signal listed in the Australian Product Information (PI). However, recent reports have raised concerns about the level of awareness and clarity regarding management of this risk.
The ACM reviewed reports of MVF events occurring as soon as seven months after the final denosumab injection. The ACM also noted that not all patients diagnosed with osteoporosis receive treatment, and among those who discontinued PROLIA, many were not transitioned to other treatment options. The ACM discussed possible contributing factors such as inaccessibility of alternative treatments, lack of repeats on prescriptions and challenges with providing timely administration of PROLIA to patients who may have mobility or cognitive issues.
The ACM recognized that the signal is known amongst clinicians but agreed that further action is required to better mitigate the risk and to ensure ongoing patient confidence and safety. The ACM recommended that the existing advice in the PI be strengthened in language and visibility, with clear, consistent, and unambiguous reminders to both medical and dental practitioners about the risks associated with discontinuation, and advice to transition patients to alternative treatments if PROLIA is to be discontinued.
The ACM stressed the importance of improving communication between GPs, physicians, dentists and community pharmacists, regarding PROLIA treatment. this includes information around treatment interruption or cessation. The ACM were supportive of the TGA releasing communications to update medical and dental practitioners on this signal and communicate the risk factors associated with rebound multiple vertebral fractures.
The ACM was also of the view that any actions taken to mitigate risk for PROLIA should also be applied to all other denosumab products indicated for the treatment of osteoporosis.
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.