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Veklury
Published
Product name
Veklury
Active ingredient
Remdesivir
Submission type
New chemical entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Veklury (remdesivir) was provisionally approved for the following therapeutic use:
Veklury has provisional approval 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 this medicine has been made based on limited data. More comprehensive evidence is required to be submitted.
The provisional registration period for the above medicine is two years starting on the day specified in the Australian Register of Therapeutic Goods (ARTG) certificate of registration.
How this medicine works
Remdesivir is an antiviral agent. Remdesivir is an adenosine nucleotide prodrug that distributes into cells where it is metabolised to form the pharmacologically active nucleoside triphosphate metabolite. Metabolism of remdesivir to remdesivir triphosphate has been demonstrated in multiple cell types. Remdesivir triphosphate acts as an analogue of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent ribonucleic acid (RNA) chains by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA-dependent RNA polymerase, which results in delayed chain termination during replication of the viral RNA. Remdesivir triphosphate is a weak inhibitor of mammalian deoxyribonucleic acid (DNA) and RNA polymerases with low potential for mitochondrial toxicity.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Veklury was considered favourable for the therapeutic use approved.
Sponsor
ARTG details