Ronapreve and Regkirona – these are two drugs for COVID-19, which were positively assessed by the Committee on Medicines for People of the European Medicines Agency (EMA) on Thursday. The Agency recommended that the preparations be approved for marketing in Europe. Both drugs contain monoclonal antibodies.
The benefits of the treatment with these drugs outweigh the possible risks, assessed the Medicines Committee (CHMP), which examined the effectiveness and safety of the preparations. Clinical trials show that the use of Ronapreve and Regkiron in the early stage of SARS-CoV-2 infection significantly reduces the risk of hospitalization and severe disease, underlined.
The EMA submitted its recommendation to the European Commission
The EMA Committee recommends approval of the use of Ronapreve for adults and adolescents over 12 years of age (provided the patient weighs more than 40 kg) in situations of increased risk of severe COVID-19 disease. The drug should be administered to patients who do not need oxygen therapy. The use of Regkiron has been recommended for adult patients only, in the same situation as for Ronapreve.
Ronapreve is produced by the American company Regeneron Pharmaceuticals and the Swiss concern Roche. Regkirona was developed by Celltrion from South Korea.
EMA submitted its recommendation to the European Commission, which formally authorizes drugs to be marketed in Europe.
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