Roche progresses Ronapreve approval in Australia

Australia’s Therapeutic Goods Administration (TGA) has granted provisional determination to the local subsidiary of Swiss pharma giant Roche (ROG: SIX) in relation to the combination therapy casirivimab + imdevimab, now trade-named 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.

Now eligible to apply for provisional registration