ROCHE Products Pty Ltd's Actemra (tocilizumab) has been granted provisional approval to be used as a treatment for COVID-19, by the Therapeutic Goods Administration (TGA).
The medication, which is currently listed on the Australian Register of Therapeutic Goods (ARTG) for use in the treatment of various types of arthritis and inflammatory conditions, is the fourth COVID-19 treatment to be given regulatory approval in Australia.
"This monoclonal antibody treatment is now also provisionally approved for the intravenous treatment of confirmed COVID-19 in hospitalised adults aged 18 years and older who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation," the TGA said.
"Tocilizumab is not intended to be used as a substitute for vaccination against COVID-19.
"Unlike other COVID-19 treatments, tocilizumab does not directly target SARS-CoV-2 proteins.
"Instead, it reduces inflammation by blocking the interleukin-6 receptor, thereby helping to slow the effects of the virus.
"Tocilizumab has been shown to decrease duration of hospitalisation, risk of being placed on mechanical ventilation and risk of death for those with severe COVID-19.
"The TGA's decision has been made on the basis of short-term efficacy and safety data."
Continued approval of this indication depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.
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