Posted by Michael Wonder on 13 Jul 2020
TGA publishes more details on its approval of COVID-19 medicine Veklury
13 July 2020 - Remdesivir granted conditional approval in record time.
The TGA approved Veklury on 10 July 2020 on a provisional basis for the treatment of Coronavirus Disease 2019 (COVID-19) in adults and adolescents (aged 12 years and older weighing at least 40 kg) with pneumonia, requiring supplemental oxygen.
The decision to approve Veklury was made based on limited data. More comprehensive evidence is required to be submitted.
The submission dossier accepted and first round evaluation commenced on 5 July 2020. The period from the acceptance of the dossier and (conditional) approval was 5 (working) days.
