On 20 August 2021 the Therapeutic Goods Administration (TGA) granted provisional determination to Celltrion Healthcare Australia Pty Ltd in relation to regdanvimab.
This monoclonal antibody treatment is now eligible to be considered by the TGA for treatment of mild-to-moderate COVID-19 in adults who are confirmed to be infected with SARS-CoV-2.
Regdanvimab is intended to prevent serious outcomes associated with COVID-19. Regdanvimab works by binding to a specific target on the SARs-CoV-2 virus-the spike receptor binding domain protein-and flags it as 'foreign' so that other parts of the immune system can help to clear it away.
The granting of a provisional determination means that the TGA has made a decision that Celltrion is now eligible to apply for provisional registration for regdanvimab in the Australian Register of Therapeutic Goods (ARTG). Provisional determination is the first step in the process. It is anticipated that Celltrion will submit an application for provisional registration shortly.
