The European Commission authorized on Friday "conditional marketing" of the antiviral remdesivir within the EU, used in the treatment of patients seriously affected by the new coronavirus. "We will spare no effort to obtain effective treatments or vaccines against the coronavirus," said Health Commissioner Stella Kyriakides, quoted in a statement, after authorization was granted less than a month after the filing. demand.
Remdesivir, the first drug authorized at EU level for the treatment of Covid-19
The green light from the Commission comes one week after the recommendation of the European Medicines Agency (EMA), against 67 days normally, and the approval of the Member States. It makes remdesivir the "first drug authorized at EU level for the treatment against Covid-19", specifies the European executive. Conditional placing on the market (CMA) is one of the EU regulatory mechanisms aimed at facilitating access to medicines "which meet an unmet medical need", in particular in "emergency situations in response" public health threats such as the current pandemic. " According to the EMA, this type of approval allows it "to recommend a medicinal product for marketing authorization with less complete data than expected", if the benefits outweigh the risks.
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Initially developed for Ebola haemorrhagic fever, this antiviral is the first therapy to have demonstrated some efficacy in patients hospitalized for Covid-19 in a clinical trial of significant size, even if the effect is considered to be modest.
Faster recovery
The EMA recommendation concerns the treatment of the new coronavirus in adults and adolescents from 12 years of age, suffering from pneumonia and needing additional oxygen, ie those "suffering from a serious illness". In its recommendation last week, the EMA indicated that a study carried out on more than 1,000 hospital patients with Covid-19 showed that those treated with remdesivir recovered on average four days faster than other patients.
Remdesivir has not been shown to prevent death.