Posted by Michael Wonder on 05 Feb 2022
TGA approves provisional determination for Gilead for COVID-19 treatment, Veklury (remdesivir), for proposed use in children and adults who are at risk of progressing to severe COVID-19
5 February 2022 - The TGA has granted a second provisional determination to Gilead 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 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.
