ADJUTOR Healthcare Pty Ltd's new orally-administered drug, sabizabulin, has been granted a provisional determination for the treatment of COVID-19 in Australia.
The Therapeutic Goods Administration (TGA) announced it had given the green light for the drug's sponsor to seek registration of the medication to be used as a treatment for hospitalised patients with moderate to severe COVID-19 who are at risk of developing Acute Respiratory Distress Syndrome and becoming seriously ill.
"Published results from clinical trials on hospitalised patients with moderate-to-severe COVID-19 showed significant reduction in hospital and ICU stays, requirement for mechanical ventilation or death compared to a placebo," the regulator said.
"Sabizabulin has a different mechanism of action from the other oral treatments for COVID-19 provisionally approved by the TGA.
"It is thought to interfere with the SARS-CoV-2 virus' ability to enter and leave cells and therefore limit its spread.
"It may additionally suppress some inflammatory reactions that can occur following infection.
"Internationally, the US Food and Drug Administration has received an Emergency Use Authorization application for sabizabulin and the UK Medicines and Healthcare Products Regulatory Agency is undertaking an expedited review.
"In making its decision to grant Adjutor Healthcare a provisional determination, the TGA considered all eligibility criteria, including evidence of a plan to submit comprehensive clinical data and the seriousness of the COVID-19 pandemic.
"Granting of the provisional determination precedes the market authorisation application and does not guarantee approval of that application."
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