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The European Medicines Agency (EMA) has cleared the way for the approval of two new drugs against Covid-19: the antibody therapy Ronapreve from the Swiss pharmaceutical company Roche and the drug Regkirona (Regdanvimab) from the manufacturer Celltrion in South Korea. This was announced by the EMA today in Amsterdam. Both drugs are intended for use in early stages of infection and are based on antiviral monoclonal antibodies.
The EMA experts had reviewed and assessed all the manufacturers’ data from studies on the efficacy and possible side effects of the drugs. After the positive recommendation, the EU Commission must make the final decision. However, this is considered a formality. So far, only one drug for the treatment of Covid 19 patients has been approved in the EU.
Further approvals planned
The drug Ronapreve consists of two antibodies (casirivimab and imdevimab). It is co-produced by the U.S. manufacturer Regeneron Pharmaceuticals and is intended to be given to people aged 12 and older who are infected with the coronavirus and are at high risk for a severe course. In Germany, this antibody combination is already used in special cases for coronavirus patients.
The drug Regkirona will be used to treat adults who have Covid-19 but do not yet require oxygen.
EU Health Commissioner Stella Kyriakides welcomed the decision. “Today we take a giant step towards achieving our goal of approving up to five new therapeutics in the EU by the end of the year.”
- source: orf.at/picture:
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