BRIEF—FDA approves new indication for Veklury in COVID-19

The US Food and Drug Administration has granted expedited approval of a supplemental new drug application (sNDA) for US biotech major Gilead Sciences’ Veklury (remdesivir) for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death.

This approval expands the role of Veklury, which is the antiviral standard of care for the treatment of patients hospitalized with COVID-19.

The expanded indication allows for Veklury to be administered in qualified outpatient settings that can administer daily intravenous (IV) infusions over three consecutive days.

The FDA has also expanded the pediatric Emergency Use Authorization (EUA) of Veklury to include non-hospitalized pediatric patients younger than 12 years of age who are at high risk of disease progression.