The Therapeutic Goods Administration (TGA) has provisionally approved Australia’s first treatment option for people severely ill with COVID-19.
The TGA granted provisional approval for Remdesivir (Veklury, manufactured by US biopharmaceutical company Gilead Sciences Pty Ltd).
Minister for Health, Greg Hunt, welcomed the move, saying the drug 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,” Mr Hunt said.
“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,” he said.
“Remdesivir has been shown to assist those who have been hospitalised with COVID symptoms.”
He said TGA was 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 European Union, Japan, and Singapore.
“Remdesivir has the potential to significantly reduce the strain on Australia’s health care system,” Mr Hunt said.
“By reducing recovery times, patients will be able to leave hospital earlier, freeing beds for those in need.”
He said provisional approval, which was limited to a maximum of six years, was made on the basis of preliminary clinical data.
The Minster said 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.
