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The European Commission granted marketing authorizations for Roche Registration GmbH’s Ronapreve (casirivimab/imdevimab) monoclonal antibody on Nov. 12, 2021. Ronapreve is one of the SARS-CoV-2 neutralizing antibodies. It is one of the first monoclonal antibodies for COVID-19 therapy to receive approval from the European Commission.
Ronapreve is a drug for the treatment of COVID-19 in adults and adolescents (12 years of age or older and weighing at least 40 kilograms) who do not require supplemental oxygen and are at increased risk for severe progression of their disease.
The drug consists of casirivimab and imdevimab, two monoclonal antibodies. A monoclonal antibody is a type of protein designed to recognize and bind to a specific structure (called an antigen). Casirivimab and Imdevimab were designed to bind to the spike protein of the SARS-CoV-2 virus at two different sites. When the drugs attach to the spike protein, the virus cannot enter the body’s cells.
The approval is supported by studies that showed a significant reduction in hospitalizations and deaths in Covid 19 patients at risk. The use of Ronapreve also reduces the risk of infection.
Outside the EU, Ronapreve is approved for use in various patient populations in Japan and conditionally in the United Kingdom. In numerous countries, including the United States, India and Canada, Ronapreve may be used by emergency approval. In total, Ronapreve is available in 50 countries.
- source: heute.at/picture:pixabay.com
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