The European Commission (EC) has granted marketing authorisation for Roche’s Ronapreve to treat non-hospitalised Covid-19 patients aged 12 years and above.
Ronapreve is a combination of monoclonal antibodies, casirivimab and imdevimab. It is designed to block SARS-CoV-2 infectivity.
Swiss firm Roche is developing this Covid-19 treatment jointly with its American partner Regeneron.
The EC approval came after Ronapreve received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
CHMP endorsed the drug after reviewing the positive results obtained from two clinical trials, REGN-COV 2067 study and REGN-COV 2069 prophylaxis study.
In the REGN-COV 2067 trial, which was performed on non-hospitalised Covid-19 patients, Ronapreve reduced hospitalisation or morality by 70%.
The REGN-COV 2069 prophylaxis study findings showed that the antibody combination reduced the risk of symptomatic infections by 81% in individuals exposed to Covid-19 but not infected when they enrolled.
Roche chief medical officer and global product development head Levi Garraway said: “We welcome this quick approval from the European Commission, which adds to the growing number of health authorities that recognise Ronapreve as an important therapy for the treatment and prevention of Covid-19.
“Although vaccinations are increasing globally, Europe is entering a fourth wave of rising cases and treatment options for the full range of disease severity and variants of concern are still needed.
We look forward to working with additional global regulatory bodies as we continue to tackle Covid-19 together.”
Ronapreve is approved in Japan and conditionally in the UK and Australia. It is also authorised for emergency use or temporary pandemic use in the US, Canada and India.