“Remdesivir is the first COVID-19 medication to be recommended for authorization in the EU,” the agency states. The European Commission still needs to approve this recommendation.
The European Medicines Agency has recommended the authorization (in English) of a “conditional marketing authorization” for the antiviral remdesivir in the European Union countries for patients with COVID-19.
This derogatory procedure allows for the expedited commercialization—over one year—of a medication whose evaluation is not yet complete. The agency’s recommendation applies to treatment for adults and adolescents aged 12 and over, suffering from pneumonia and requiring supplemental oxygen, meaning those “suffering from a severe illness.”
Remdesivir is the first medication to be subject to such a recommendation since the start of the health crisis. It will be marketed in Europe under the name Veklury, with a price that is not yet set, intended for adults and adolescents with pneumonia, provided that the European Commission approves this recommendation, likely within the week. The agency notably bases its decision on an American study (in English), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).
