On 20 August 2021 the Therapeutic Goods Administration (TGA) granted provisional determination to Roche Products Pty Ltd in relation to the combination therapy casirivimab + imdevimab (RONAPREVE).
This combination monoclonal antibody treatment is now eligible to be considered by the TGA for the treatment of confirmed COVID-19 in patients aged 12 years and older and weighing at least 40 kg that do not require supplemental oxygen for COVID-19 and who are at high risk of progressing to severe COVID-19. RONAPREVE will also be considered for the prevention of COVID-19 in patients of the same age who have been exposed to or are at high risk of exposure to SARS-CoV-2 and/or have a medical condition that makes them unlikely to be protected by vaccination.
The combination of casirivimab + imdevimab is intended to prevent serious outcomes associated with COVID-19. The two different monoclonal antibodies, casirivimab and imdevimab, bind to two different sites of the SARS-CoV-2 spike protein and flags the spike protein as 'foreign' so that other parts of the immune system can help to clear it away.
The granting of a provisional determination means that the TGA has made a decision that Roche Products Pty Ltd is now eligible to apply for provisional registration for RONAPREVE in the Australian Register of Therapeutic Goods (ARTG). Provisional determination is the first step in the process. It is anticipated that Roche Products Pty Ltd will submit an application for provisional registration shortly.
