- Australia’s Therapeutic Goods Administration (TGA) has approved Sotrovimab as a COVID-19 treatment.
- Overseas, Sotrovimab has reduced hospitalisation or death by 79% in adults with mild to moderate COVID-19.
- Vaccination remains the most important and safest way for Australians to protect themselves.
- Need someone to talk to? Call our COVID-19 Support Line for more information or a chat on 1300 887 626.
Treating people who have COVID-19 is as important as vaccinating people against the virus. But there have been few treatment options for doctors to choose from. Until now.
The good news is that Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval for Sotrovimab to be used in Australia.
The treatment has the potential to keep people out of hospital, prevent their disease from progressing and reduce the burden on the health system.
It is expected that Sotrovimab will be used for the treatment of Australians over 55-years-old who have COVID-19 and have one or more of the following risk factors for disease progression – diabetes, obesity, chronic kidney disease, heart failure, lung disease and moderate to severe asthma.
The Health Department says the Australian Government secured an initial allocation of over 7,700 doses of Sotrovimab. The first shipment is already in the country and ready to be deployed through the National Medical Stockpile from 15 August.
The Sotrovimab treatment requires a single dose to be administered through an intravenous (IV) infusion in a health care facility. It has been shown to reduce hospitalisation or death by 79% in adults with mild to moderate COVID-19, who are at risk of developing severe COVID-19.
Dr. Krystal Evans, Medical Lead for COVID-19 Therapeutics at GSK Australia, says the provisional approval is an important milestone in the strategy to combat COVID-19 in Australia.
“Sotrovimab is the first monoclonal antibody treatment approved for COVID-19 in Australia. We think this new treatment option could play a role in our longer-term management of COVID-19 as part of Australia’s pandemic response toolkit,” said Dr Evans.
“If we can treat people at the time of diagnosis, then we may be able to prevent the disease from getting more serious and help keep people out of hospital.”
“Vaccination remains the most important and safest way for Australians to protect themselves and their loved ones from COVID-19 – and I continue to thank Australians for their take up of the COVID-19 vaccine,” Health Minister Greg Hunt said.
People who are asymptomatic or who are not at risk of developing severe COVID-19 will not require Sotrovimab.
The Health Department says medical experts estimate that 8% to 15% of adults with COVID-19 will be recommended for treatment with Sotrovimab and this treatment must be given within five days of symptoms onset.
Where a doctor prescribes the treatment for patients with mild to moderate COVID-19, who are at risk of developing severe COVID-19, it will be made available free of charge through the public health system.
It is the second COVID-19 treatment to receive regulatory approval in Australia, following the TGA’s approval of Remdesivir.
Sotrovimab is approved for emergency use in the US, Singapore and Canada, however Australia is the first OECD country to issue a formal regulatory approval.
Source: Department of Health, GSK Australia & Vir Biotechnology Media Statements