Australian Regulatory Body Grants Approval for New COVID-19 Treatment

The logo of the Therapeutic Goods Administration is seen at a COVID-19 vaccines press conference in Canberra, Australia, on May 6, 2021. AAP Image/Lukas Coch

The Australian Therapeutic Goods and Drugs Administration (TGA) has granted provisional approval for the use of the drug tocilizumab in the treatment of COVID-19.

Sold under the brand name “ACTEMRA” and produced by Roche, the drug is already an approved treatment for arthritis and inflammatory conditions and is the fourth COVID-19 treatment to be given regulatory approval in Australia.

In a media release on Wednesday, the TGA stated tocilizumab is a monoclonal antibody treatment that can be used intravenously to treat hospitalised people aged 18 and above who are confirmed to have  COVID-19 are receiving systemic corticosteroids and require oxygen supplementation or mechanical ventilation.

The new drug works by not directly targeting SARS-CoV-2 proteins and instead works to reduce inflammation by blocking interleukin-6 receptors, which helps slow down the effects of the virus.

Tocilizumab has also been shown to reduce time in hospital, as well as minimise the risk of requiring mechanical ventilation and the risk of death in people with severe COVID-19.

As the TGA’s approval of tocilizumab has been granted on the basis of short-term efficacy and safety data, continued approval will be subject to evidence of longer-term efficacy and safety from ongoing clinical trials.

“Australians can be confident that the TGA’s review process of tocilizumab (ACTEMRA) was rigorous. The decision to provisionally approve this treatment was also informed by expert advice from the Advisory Committee on Medicines, an independent committee with expertise in scientific and medical fields including consumer representation,” the TGA said.

However, the approval came after the TGA declared Australia had a shortage of the drug in October after a global supply shortage of tocilizumab became apparent in July 2021. The TGA expects supply to stabilise by early 2022.

The other three treatments for COVID-19 currently approved in Australia are casirivimab+imdevimab (RONAPREVE), Sotrovimab (XEVUDY), and remdesivir (VEKLURY).

RONAPREVE works by targeting the SARS-CoV-2 virus and binding to distinct regions of the spike protein, rendering the virus unable to infect healthy cells. This drug has been shown to reduce the risk of severe infection and hospitalisation in mild to moderate cases of COVID-19.

Similarly, the European Medical Association (EMA) states that XEVUDY works by binding to spike proteins, which prevents the virus from entering cells, whereas according to the NIH, VEKLURY interferes with key enzymes needed for the virus to replicate its RNA, hence preventing it from multiplying.

The former can reduce hospitalisation or death in those with mild to moderate infection and who do not need oxygen supplementation, while the latter is only used in hospitalised patients who are suffering from severe infection, potentially reducing their time in hospital.

The TGa stressed though that Tocilizumab “is not intended to be used as a substitute for vaccination against COVID-19.”