TGA grants provisional determination for sabizabulin for the treatment of COVID-19

On 19 August 2022 the Therapeutic Goods Administration (TGA) granted a provisional determination to Adjutor Healthcare Pty Ltd for a new orally-administered medicine, sabizabulin for treatment of COVID-19.

The determination means that Adjutor Healthcare is now able to apply for provisional registration of sabizabulin for treatment of SARS-CoV-2 infection in hospitalised patients with moderate-to-severe COVID-19 infection and at high 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.

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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