First monoclonal antibody treatment for COVID approved

The TGA has announced its approval of the first monoclonal antibody treatment for COVID-19 in Australia

Australians with COVID-19 who are at risk of hospitalisation will now have access to an additional antibody treatment, as TGA announced on Friday that it has granted provisional approval for sotrovimab to be used in Australia.

According to a statement by Health Minister Greg Hunt, earlier this month, the Australian Government secured an initial allocation of more than 7,700 doses of the novel monoclonal antibody treatment.

He said a first shipment is already in the country and ready to be deployed through the National Medical Stockpile from next week.

The sotrovimab treatment requires a single dose to be administered through an intravenous infusion in a health care facility and 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.

“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,” Minister Hunt said.

“This treatment will provide another tool in the ongoing challenge against COVID-19, in addition to the COVID-19 vaccines, which are being rolled out in record numbers across the country.”

He said it is expected that sotrovimab will be targeted for the treatment of Australians over 55 years old who have COVID-19 and also have one or more risk factors for disease progression:  diabetes, obesity, chronic kidney disease, heart failure, lung disease and moderate to severe asthma.

Sotrovimab is to be used for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg).

The National COVID-19 Clinical Evidence Taskforce is finalising its recommendation for use. 

People who are asymptomatic or who are not at risk of developing severe COVID-19 will not require access to sotrovimab.

According to the Minister, medical experts estimate that eight to 15% of adults with COVID-19 will be recommended for treatment with sotrovimab. The treatment must be given within five days of symptoms onset.

Earlier this month, he noted that “Sotrovimab will not be the last of these sorts of announcements. As we did last year, we are constantly looking at what is happening in those new developments”.

GSK Australia and Vir Biotechnology welcomed the move.

Dr Krystal Evans, Medical Lead for COVID 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. 

“Vaccines are a critical element in our response to the pandemic and we also need to have a range of interventions available if people do become infected, to keep people out of hospital and reduce the severity of the disease. 

“This means social distancing, hand washing, mask-wearing, vaccination and effective evidenced-based treatment options.”

The TGA had previously granted sotrovimab a provisional determination in April.

As reported earlier this month, the European Medicines Agency (EMA) completed its review of sotrovimab for treating COVID-19 in May 2021, concluding that the drug can be used to treat confirmed COVID-19 in adults and some adolescents who do not require supplemental oxygen therapy and who are at risk of progressing to severe COVID-19.

This month, the National Institutes of Health (NIH) in the US also added sotrovimab as a recommended treatment for non-hospitalised patients with mild to moderate COVID-19 who are at high risk for clinical progression.

Where a doctor prescribes this treatment for their 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.

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