TGA grants provisional nod to Gilead COVID-19 treatment, Veklury

9 May 2022

Australia regulator the Therapeutic Goods Administration (TGA) has granted provisional approval for Gilead Sciences (Nasdaq: GILD) to extend the use of its COVID-19 treatment, Veklury (remdesivir). Provisionally approved uses now include:

adults and pediatric patients (at least four weeks of age and weighing at least 3 kg) who have pneumonia due to SARS-CoV-2, who require supplemental oxygen, and
adults and pediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.

The decision follows the provisional approval granted by the TGA to Gilead Sciences Pty on July 10, 2020 for the use of Veklury in adults and adolescents aged 12 years and older (and weighing at least 40 kg) with pneumonia who have been hospitalized and require oxygen. This was the first treatment option for COVID-19 to be provisionally approved by the TGA.

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