Australia’s first treatment option for people who are seriously ill with COVID-19 has received temporary approval from the Therapeutic Goods Administration (TGA).
The TGA approval has given remdesivir (“Veklury”, produced by Gilead Sciences Pty Ltd) temporary approval for use in adults and adolescent patients with severe symptoms of COVID-19 who have been hospitalized.
The Minister of Health, Greg Hunt, welcomed the agreement, and said it would be available for Australians who were very unhealthy, needed oxygen or high-level support for breathing, and in hospital treatment.
“This is a major milestone in Australia’s response to the COVID-19 pandemic. This is not prevention or cure for those who have mild symptoms, but is an important part of our response to support those most affected. remdesivir has been proven to help those who are hospitalized with symptoms of COVID, “Minister Hunt said.
“Australia, through TGA, was one of the first regulators in the world to authorize the use of remdesivir for the treatment of COVID-19, following on from recent agreements in the European Union, Japan and Singapore.
“Remdesivir is one of the most promising treatment options so far to reduce hospitalization time for those who suffer from severe COVID.
“Remdesivir has the potential to significantly reduce pressure on the Australian health care system. By reducing recovery time, patients will be able to leave the hospital early, freeing up beds for those in need. “
The preliminary agreement, which is limited to a maximum of six years, is based on preliminary clinical data. Gilead can submit full registration when additional clinical data needed by the TGA to confirm the safety and efficacy of the drug is available.
The use of remdesivir will occur in hospitals and under the strict control and supervision of the treating doctor.
Unlike other countries, there are remdesivir supplies available in Australia including supplies that have been donated to the National Medicines by the company, Gilead. It 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 medicines in the medium to long term.
The government is grateful to Gilead for their collaborative approach in making remdesivir available for Australian patients with COVID-19.
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