TGA grants provisional determination to Roche Products Pty Ltd...

TGA grants provisional determination to Roche Products Pty Ltd combination COVID-19 treatment casirivimab + imdevimab (RONAPREVE)
23 August 2021
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.

This is preventative medication. Remistemcel-L treats those who are on oxygen. Too late for this medication.
Remistemcel-L treats the symptoms of ARDS. If a person develops ARDS, it is too late for Ronapreve.