On 6 May 2022, the Therapeutic Goods Administration (TGA) provisionally approved the expanded use of Veklury (remdesivir) in Australia.
According to a recent media release, the Australian regulator has allowed the COVID-19 treatment’s use in:
“adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) who have pneumonia due to SARS-CoV-2, who require supplemental oxygen, and… [those]…(weighing at least 40 kg) who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19".
The approval decision followed the TGA's consideration of two studies: the CARAVAN Study (study GS-US-540-5823); and the PINETREE study (study GS-US-540-9012).
The TGA’s provisional approval for expanded use follows the United States Food and Drug Administration’s (FDA) recent decision to also expand Veklury’s approval. The FDA’s decision and rationale are detailed in a news release found here.
Further details regarding the TGA’s expanded provisional approval of Veklury can be found in the relevant Australia public assessment report (AusPAR) for remdesivir dated 6 May 2022.
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