On 1 December 2021, the Therapeutic Goods Administration (TGA) granted provisional approval to Roche Products Pty Ltd for the use of tocilizumab (ACTEMRA) for the treatment of COVID-19. This is the fourth COVID-19 treatment to receive regulatory approval in Australia.
Tocilizumab (ACTEMRA) is already approved and included in the Australian Register of Therapeutic Goods (ARTG) for use in the treatment of various types of arthritis and inflammatory conditions.
This monoclonal antibody treatment is now also provisionally approved for the intravenous treatment of confirmed COVID-19 in hospitalised adults aged 18 years and older who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
Tocilizumab (ACTEMRA) is not intended to be used as a substitute for vaccination against COVID-19.
Unlike other COVID-19 treatments, tocilizumab (ACTEMRA) does not directly target SARS-CoV-2 proteins. Instead, it reduces inflammation by blocking the interleukin-6 receptor, thereby helping to slow the effects of the virus. Tocilizumab (ACTEMRA) has been shown to decrease duration of hospitalisation, risk of being placed on mechanical ventilation and risk of death for those with severe COVID-19.
The TGA's decision has been made on the basis of short-term efficacy and safety data. Continued approval of this indication depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.
To date, tocilizumab (ACTEMRA) has been granted emergency use authorisation in the United States.
Tocilizumab (ACTEMRA) products have been in global shortage since July 2021 and supply is expected to stabilise in early 2022. The TGA has been working closely with the Medicine Availability Working Group, States and Territories, the Australian Rheumatology Association, Arthritis Australia, Medicines Australia, the manufacturer (Roche) and the National Pharmaceutical Services Association and other pharmaceutical wholesalers to manage the supply of tocilizumab for the existing TGA approved indications. Tocilizumab (ACTEMRA) for the treatment of COVID has been procured by states and territories for supply to patients in public hospitals and the Department of Health will continue to work closely with jurisdictions to manage supply.
Australians can be confident that the TGA's review process of tocilizumab (ACTEMRA) was rigorous. The decision to provisionally approve this treatment was also informed by expert advice from the Advisory Committee on Medicines, an independent committee with expertise in scientific and medical fields including consumer representation.
The TGA continues to work very closely with international regulators to harmonise regulatory approaches, share information and where it speeds up evaluation, collaboratively review new treatments.
Supporting regulatory documents
The provisional approval pathway provides a formal and transparent mechanism for registration of promising new medicines with preliminary clinical data.
The following regulatory documents are made available as part of this process:
- Product information (PI)
- Consumer Medicine Information (CMI)
- AusPAR: Tocilizumab (ACTEMRA)
An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission.