EMA Assessing Remdesivir for COVID-19 Expanded Indication
The European Medicines Agency (EMA) is evaluating remdesivir data submitted by Gilead Sciences to determine whether the antiviral’s indication should be expanded to cover adult COVID-19 patients who don’t need supplemental oxygen.
The agency’s recommendation, which it expects to provide before the summer, would need to be accepted by the European Commission, which will have the final say in authorizing or rejecting the proposed expanded indication.
The drug was granted conditional marketing authorization in the EU in July 2020 for treating COVID-19 in adults and adolescents with pneumonia who require supplemental oxygen. The EMA explained at the time that although there were less data than it would normally expect, the drug’s benefits appeared to outweigh its risks.