Roche (SIX: RO, ROG; OTCQX: RHHBY) today 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.
About Ronapreve™ (casirivimab and imdevimab)
Ronapreve™ (casirivimab and imdevimab, known as REGEN-COV®in the United States), which is jointly developed by Roche and Regeneron, has been approved for use in Japan and conditionally in Australia and the United Kingdom, and is authorised for emergency or temporary pandemic use in additional territories such as the United States, India and Canada. It has also been conditionally recommended by WHO. Currently, Ronapreve is available in nearly 50 countries via bilateral purchase agreements, including upper-middle-income and lower-middle-income countries.
In parallel to the EMA’s rolling review, the CHMP issued a scientific opinion (under Article 5(3) of Regulation 726/2004) in February 2021, supporting the use of Ronapreve as a treatment option for patients with confirmed COVID-19 who do not require oxygen supplementation and who are at high risk for progressing to severe COVID-19. The scientific opinion can be used by EU member states to support national decision making before a formal authorisation is issued.
The efficacy and safety of Ronapreve have been studied across multiple phase III clinical trials in non-hospitalised and hospitalised COVID-19 patients, and in the preventive setting. In addition, data from preclinical studies showed that Ronapreve retained neutralisation activity against key emerging variants, as referenced in publications in Cell and Nature.
The CHMP’s decision is based on data from multiple studies, including:
the REGN-COV 2067 study, showing that Ronapreve reduced hospitalisation or death by 70% and symptom duration by four days.
the REGN-COV 2069 study, showing that the administration of Ronapreve reduced the risk of symptomatic infections by 81% in those who were not infected when they entered the trial.
There have been no new safety signals identified for Ronapreve in these studies.
Ronapreve is a combination of two monoclonal antibodies, casirivimab and imdevimab, and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19.
About Roche's response to the COVID-19 pandemic
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