Australia’s first treatment option for people severely ill with COVID-19 has received provisional approval from the Therapeutic Goods Administration (TGA).
The TGA approval has granted remdesivir ('Veklury', manufactured by Gilead Sciences Pty Ltd) provisional approval for use in adults and adolescent patients with severe COVID-19 symptoms who have been hospitalised.
Minister for Health, Greg Hunt, welcomed the approval, and said it would be available to Australians who were severely unwell, requiring oxygen or high level support to breathe, and in hospital care.
“This is a major milestone in Australia’s response against the COVID-19 pandemic. It is not a prevention or a cure for those with mild symptoms but it is an important part of our response to support those who are most impacted. Remdesivir has been shown to assist those who have been hospitalised with COVID symptoms,” Minister Hunt said.
“Australia, through TGA, is one of the first regulators in the world to authorise the use of remdesivir for the treatment of COVID-19, following on from recent approvals in the European Union, Japan, and Singapore.
“Remdesivir is one the most promising treatment options so far to reduce hospitalisation time for those suffering from severe COVID.
“Remdesivir has the potential to significantly 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.”
Provisional approval, which is limited to a maximum of 6 years, was made on the basis of preliminary clinical data. Gilead may apply for full registration when additional clinical data required by the TGA to confirm the safety and efficacy of the medicine is available.
The use of remdesivir will occur in hospitals and under strict controls and supervisions from the treating doctor.
Unlike other countries, there are existing supplies of remdesivir in Australia including supply that has been donated to the National Medicines Stockpile by the company, Gilead. These will be available for use immediately over the coming weeks for suitable patients.
Now that remdesivir has received regulatory approval in Australia, the Government is working with Gilead on options for sustainable supply of the medicine over the medium to longer term.
The Government thanks Gilead for their collaborative approach in making remdesivir available for Australian patients with COVID-19.