Australian regulator grants approval for new COVID-19 treatment

The Australian Therapeutic Goods Authority (TGA) has given interim approval for the use of tocilizumab in the treatment of COVID-19.

Sold under the brand name “ACTEMRA” and manufactured by Roche, the drug has already been approved for the treatment of arthritis and inflammatory conditions and is the fourth COVID-19 treatment to be approved by regulatory agencies in Australia. ..

so Media release On Wednesday, TGA, tocilizumab, can be given intravenously to treat inpatients aged 18 years or older who are receiving COVID-19 systemic corticosteroids and require oxygenation or mechanical ventilation. He said it was a monoclonal antibody treatment.

The new drug works to reduce inflammation by blocking the SARS-CoV-2 protein rather than directly targeting it. Interleukin 6 receptor, Helps slow down the effects of the virus.

Tocilizumab has also been shown to not only reduce hospital stays, but also minimize the risk of needing a ventilator and the risk of death in patients with severe COVID-19.

Because tocilizumab TGA approval is based on short-term efficacy and safety data, continued approval is evidence of long-term efficacy and safety from ongoing clinical trials. It is a target.

“Australian can be confident that the TGA review process for tocilizumab (ACTEMRA) was rigorous. The decision to tentatively approve this treatment is Pharmaceutical Advisory Board, An independent committee with scientific and medical expertise, including consumer representatives, “said TGA.

However, approval came after the TGA declared a drug shortage in Australia in October after the global supply shortage of tocilizumab was revealed in July 2021. TGA expects supply to stabilize by early 2022.

The other three treatments for COVID-19 currently approved in Australia are Casilivimab + Imdevimab (RONAPREVE), Sotrovimab (XEVUDY), and Remdesivir (VEKLURY).

RONAPREVE works by targeting the SARS-CoV-2 virus and binding to different regions of the peplomer to prevent the virus from infecting healthy cells. This drug has been shown to reduce the risk of severe infections and hospitalization in mild to moderate cases of COVID-19.

Similarly, European Medical Society According to the (EMA), XEVUDY functions by binding to peplomer proteins, preventing the virus from invading cells. NIH (National Institutes of Health), VEKLURY prevents the virus from multiplying because it interferes with the major enzymes that the virus needs to replicate RNA.

The former can reduce hospitalization or death in patients with mild to moderate infections who do not require oxygen supplementation, while the latter is used only for inpatients suffering from severe infections and reduces hospital stays. There is likely to be.

TGa emphasized that tocilizumab is “not intended to be used as an alternative to vaccination against COVID-19.”

Steve Milne