On 15 October 2021, the Therapeutic Goods Administration (TGA), part of the Department of Health, granted provisional approval to Roche Products Pty Ltd for its COVID-19 treatment - casirivimab + imdevimab (RONAPREVE) - making it the third COVID-19 treatment to receive regulatory approval in Australia.

This combination monoclonal antibody treatment, is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for the treatment of COVID-19 in adults and adolescents aged 12 years and older and weighing at least 40 kg who do not require supplemental oxygen for COVID-19 and who are at increased risk of progressing to severe COVID-19.

In addition, RONAPREVE has received provisional approval for the prevention of COVID-19 in patients of the same age and weight as for treatment who have been exposed to SARS-CoV-2 and who either have a medical condition making them unlikely to respond to or be protected by vaccination, who have not been vaccinated against COVID-19.

RONAPREVE is not intended to be used as a substitute for vaccination against COVID-19.

RONAPREVE (casirivimab + imdevimab) targets the SARS-CoV-2 virus by simultaneously binding to distinct regions of the spike protein, thereby preventing the virus from infecting healthy cells. RONAPREVE has been shown to reduce the risk of severe infection and hospitalisation for those with mild to moderate 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, casirivimab + imdevimab (RONAPREVE) has been granted regulatory approval or emergency authorisation in a number of jurisdictions including the United States, the United Kingdom, Brazil, Canada and Japan.

Australians can be confident that the TGA's review process of casirivimab + imdevimab (RONAPREVE) was rigorous. The decision to provisionally approve this treatment was also informed by expert advice from the Advisory Committee on Medicines (ACM), an independent committee with expertise in scientific, medical and clinical fields including consumer representation. The ACM reiterated its view that vaccination is the preferred and primary option to prevent COVID-19.

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) (pdf,592kb)
• Consumer Medicine Information (CMI) (pdf,604kb)
• casirivimab + imdevimab (RONAPREVE) Decision Summary
  The decision summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the ARTG.
• The AusPAR casirivimab + imdevimab (RONAPREVE) will be published shortly.
• Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Roche) (Casirivimab and Imdevimab) Labelling Exemption 2021