Roche announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of the antibody combination, Ronapreve (casirivimab and imdevimab), for treating COVID-19 in adults and adolescents (from 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 weighing at least 40 kilograms (pre- or post-exposure prophylaxis). A final decision regarding the approval of Ronapreve is expected from the European Commission in the near future.
“With cases in Europe surging, it is vital that people have access to different approaches, in addition to vaccines, that reduce the disease burden, and Ronapreve has demonstrated efficacy in treating and preventing COVID-19 and against variants of concern,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “People with COVID-19 across Europe are already being treated with Ronapreve based on emergency authorisations that followed the CHMP’s scientific opinion earlier this year, and we’re pleased that the committee has now recommended the approval of the antibody combination.”
In February, the EMA’s CHMP initiated a rolling review of Ronapreve, one of the regulatory tools used to speed up the assessment of a promising medicine during a public health emergency. Today’s recommendation is based on positive data from the REGN-COV 2067 treatment study in non-hospitalised patients and the REGN-COV 2069 prophylaxis study in people exposed to SARS-CoV-2 virus.
In these exceptional times, Roche stands together with society, governments, healthcare providers and all those working towards the common goal of overcoming the COVID-19 pandemic.