TGA Provisional Approval of Roche Products Pty Ltd COVID-19 treatment, casirivimab + imdevimab (RONAPREVE)

The Therapeutic Goods Administration (TGA) has provisionally approved the use of the Roche Products Pty Ltd combination therapy, casirivimab + imdevimab (RONAPREVE), for the treatment and prevention of COVID-19 in specific target populations.

RONAPREVE now has provisional approval for treating 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 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.

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 RONAPREVE was rigorous. Provisional approval has been made following careful evaluation of the available data supporting safety and efficacy, including clinical studies. Use in these target groups was supported by the independent expert Advisory Committee on Medicines.

Further details of the data supporting this approval and TGA's evaluation are included in the Product Information (PI) and the Decision Summary.

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.