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COVID-19 treatment: Gilead Sciences Pty Ltd, remdesivir (VEKLURY)
On 10 July 2020 the Therapeutic Goods Administration (TGA) granted provisional approval to remdesivir ('VEKLURY', Gilead Sciences Pty Ltd) as the first treatment option for COVID-19. It received provisional approval for use in adults and adolescent patients with severe COVID-19 symptoms who have been hospitalised.
Remdesivir is a treatment option that reduces hospitalisation time for those suffering from severe coronavirus infections. Remdesivir offers the potential to reduce the strain on Australia's health care system. By reducing recovery times patients will be able to leave hospital earlier, freeing beds for those in need. Remdesivir will not be available to Australians unless they are severely unwell, requiring oxygen or high-level support to breathe, and in hospital care.
Australia was one of the first regulators to authorise the use of remdesivir for the treatment of COVID-19, following on from approvals in European Union, Japan, and Singapore. International regulatory cooperation played a significant role, as the European Medicines Agency and the Singapore Health Sciences Authority generously shared their review reports with TGA at an early stage.
TGA's approval was able to be made within 2 weeks of the receipt of the submission with a large multidisciplinary review team at TGA working around the clock.
Provisional approval, which is limited to a maximum of six years, was made on the basis of preliminary clinical data, as there is the potential for substantial benefit to Australian patients. The sponsor, Gilead Sciences Pty Ltd may apply for full registration when additional clinical data required by the TGA to confirm the safety and efficacy of the medicine are available.
Supporting regulatory documents
The provisional approval pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data.
The following regulatory documents are made available as part of this process:
- Product Information (PI)
- Consumer Medicine Information (CMI)
The decision summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the ARTG.
An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission.
- Advisory Committee on Medicines meeting statement
An independent expert committee that provides advice on an application to register a new medicine. Further details of the ACM discussion and advice associated with remdesivir are released within the AusPAR for Remdesivir.
- Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Gilead) (Remdesivir) Labelling Exemption 2021