11.15.21
Roche received marketing authorization from the European Commission for Ronapreve (casirivimab and imdevimab), to treat COVID-19 in adults and adolescents (12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe, and for preventing COVID-19 in people aged 12 years and older pre- or post-exposure prophylaxis.
The decision is based on the EMA ’s CHMP ’s review of positive data from the REGN-COV 2067 treatment study in non-hospitalized patients and the REGN-COV 2069 prophylaxis study in people exposed to SARS-CoV-2 virus. Roche will continue to work with the EMA to potentially extend the marketing authorization of Ronapreve to treat hospitalized patients with COVID-19.
Ronapreve was also approved for use in Japan and conditionally in the UK and Australia, and is authorized for emergency or temporary pandemic use in additional territories. Ronapreve, being jointly developed by Roche and Regeneron, is currently available in nearly 50 countries.
The decision from the European Commission is based on data from multiple studies, including the REGN-COV 2067 study, showing that Ronapreve reduced hospitalization or death by 70% and symptom duration by four days, and the REGN-COV 2069 study, showing that Ronapreve reduced the risk of symptomatic infections by 81% in those who were not infected when they entered the trial.
“We welcome this quick approval from the European Commission, which adds to the growing number of health authorities that recognize Ronapreve as an important therapy for the treatment and prevention of COVID-19,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “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.”
The decision is based on the EMA ’s CHMP ’s review of positive data from the REGN-COV 2067 treatment study in non-hospitalized patients and the REGN-COV 2069 prophylaxis study in people exposed to SARS-CoV-2 virus. Roche will continue to work with the EMA to potentially extend the marketing authorization of Ronapreve to treat hospitalized patients with COVID-19.
Ronapreve was also approved for use in Japan and conditionally in the UK and Australia, and is authorized for emergency or temporary pandemic use in additional territories. Ronapreve, being jointly developed by Roche and Regeneron, is currently available in nearly 50 countries.
The decision from the European Commission is based on data from multiple studies, including the REGN-COV 2067 study, showing that Ronapreve reduced hospitalization or death by 70% and symptom duration by four days, and the REGN-COV 2069 study, showing that Ronapreve reduced the risk of symptomatic infections by 81% in those who were not infected when they entered the trial.
“We welcome this quick approval from the European Commission, which adds to the growing number of health authorities that recognize Ronapreve as an important therapy for the treatment and prevention of COVID-19,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “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.”
