EC Gives Full Marketing Authorization to Gilead Sciences’ Veklury

The European Commission (EC) has granted a full marketing authorization to Gilead Sciences’ Veklury (remdesivir) for treatment of COVID-19 infections. The antiviral drug was previously under conditional marketing authorization.

Veklury is now authorized for adults and adolescents — from 12 years of age and weighing at least 40 kilograms — with pneumonia requiring supplemental oxygen. It can also be used for adults who do not require supplemental oxygen and who are at increased risk of developing severe COVID-19.

The switch from conditional to full authorization was supported by additional data confirming the medicine’s activity against different variants of SARS-CoV-2.

The drug will continue to be closely monitored to assess its effectiveness against emerging SARS-CoV-2 variants.