TGA approves provisional determination for Gilead Sciences Pty Ltd for COVID-19 treatment, VEKLURY (remdesivir), for proposed use in children and adults who are at risk of progressing to severe COVID-19

The Therapeutic Goods Administration (TGA), part of the Department of Health, has granted a second provisional determination to Gilead Sciences Pty Ltd in relation to its COVID-19 treatment, VEKLURY (remdesivir).

Currently, VEKLURY is provisionally approved for use in adults and adolescent patients with severe COVID-19 symptoms who have been hospitalised and require oxygen. This determination means that Gilead Sciences is eligible to apply to vary the provisional approval for use in children and adults who have not yet progressed to severe COVID-19 (those not in hospital). Gilead Sciences has now submitted initial application documents for the TGA's evaluation.

In making its decision to grant Gilead a provisional determination, the TGA considered evidence of a plan to submit comprehensive clinical data in relation to use in children and those with non-severe COVID-19.

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