On 6 December 2021, the Therapeutic Goods Administration (TGA) granted provisional approval to Celltrion Healthcare Australia Pty Ltd for the use of regdanvimab (REGKIRONA) for the treatment of COVID-19. This is the fifth COVID-19 treatment to receive regulatory approval in Australia.

This monoclonal antibody treatment is now provisionally approved for the intravenous treatment of mild-to-moderate COVID-19 in adult patients who are confirmed to be infected with the SARS-CoV-2 virus.

Regdanvimab (REGKIRONA) is intended to prevent serious outcomes associated with COVID-19. Regdanvimab (REGKIRONA) works by binding to a specific target on SARs-CoV-2 - the spike receptor binding domain protein - and flags it as 'foreign' so that other parts of the immune system can help to clear it from the body. Regdanvimab (REGKIRONA) is not intended to be used as a substitute for vaccination against 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.

To date, regdanvimab has received market authorisation by the European Medicines Agency (EMA). It has also been granted regulatory approval in the Republic of Korea and emergency use authorisations in Indonesia and Brazil.

Australians can be confident that the TGA's review process of regdanvimab (REGKIRONA) was rigorous. The decision to provisionally approve this treatment was also informed by expert advice from the Advisory Committee on Medicines, an independent committee with expertise in scientific and medical fields including consumer representation.

The TGA continues to work very closely with international regulators to harmonise regulatory approaches, share information and where it speeds up evaluation, collaboratively review new treatments.

Supporting regulatory documents

The provisional approval pathway provides a formal and transparent mechanism for registration of promising new medicines with preliminary clinical data.

The following regulatory documents are made available as part of this process:

• Product information (PI) (pdf,335kb)
• Consumer Medicine Information (CMI) (pdf,222kb)
• Decision Summary
  The decision summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the ARTG.
• AusPAR regdanvimab (REGKIRONA)
  An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission.
• Advisory Committee on Medicines meeting statement
  An independent expert committee that provides advice on an application to register a new medicine. Further details of the ACM discussion and advice associated with remdesivir are released within the AusPAR regdanvimab (REGKIRONA)