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EMA recommends conditional marketing authorization to Remdesivir
Published in The Saudi Gazette on 26 - 06 - 2020

European Medicine Agency's (EMA) human medicines committee (CHMP) has recommended the granting of a conditional marketing authorization to Remdesivir for the treatment of COVID-19 in adults and adolescents from 12 years of age.
The authorization would cover COVID-19 patients with pneumonia who require supplemental oxygen. The European Commission needs to endorse the recommendation.
Remdesivir is the first medicine against COVID-19 to be recommended for authorization, in the EU.
"Remdesivir is the first COVID-19 drug to be recommended for authorization in the EU," the agency said in a statement.
Data on Remdesivir were assessed in an exceptionally short timeframe through a rolling review procedure, an approach used by EMA during public health emergencies to assess data as they become available.
A study conducted in April showed patients with coronavirus treated with the antiviral drug Remdesivir recovered in 11 days compared to 15 days for those who received a placebo.
It meant patients treated with the drug had a 31 percent faster recovery time than those who received a placebo. The study, sponsored by the US National Institutes of Health, began in February and included 1,063 patients in the US, Europe, and Asia.
Remdesivir interferes with an enzyme that helps RNA viruses to replicate and has been shown to be successful against coronaviruses in laboratory studies. It was initially developed to help treat Ebola during the outbreak in West Africa. — SPA/agencies


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