Sydney, December 8th, 2021 – Celltrion Healthcare Australia Pty Ltd is pleased to confirm that Therapeutic Goods Administration (TGA) has granted provisional approval of Regkirona (regdanvimab), a monoclonal antibody for the treatment of mild-to-moderate COVID-19 in adults infected with SARS-CoV-2.1
Regkirona is administered as a single intravenous infusion in a hospital setting to prevent serious outcomes associated with COVID-19. It works by binding to a specific target on the SARs-CoV-2 virus – the spike receptor binding protein – and flags it as 'foreign' so that other parts of the immune system can help clear it away.
To date, Regkirona has received marketing 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, Brazil and conditional approval in Peru.
"The announcement today is a significant step forward for Australia's response to COVID-19, particularly in the hospital setting where resources remain in demand. Although Australia's vaccination rates are increasing, emerging new strains are indicating the need to remain vigilant and on the front foot with treatment options in our ongoing medical response to the pandemic," states Associate Professor Paul Griffin, practicing infectious diseases physician and clinical microbiologist at the University of Queensland. "Regkirona offers an option for those at high-risk of progressing to severe COVID-19, especially in cases where possible drug-drug interactions need to be considered."
"Today's announcement underscores our ongoing commitment to addressing the world's greatest health challenges and represents significant part of Celltrion Healthcare's commitment to providing more options to patients, and more specifically our commitment to the COVID-19 pandemic," said Cecilia Sung, Country Manager, Australia and New Zealand.
"As part of our global efforts to accelerate access to this treatment, we have been communicating with a number of governments across the world, including Australia. Celltrion will continue working with all stakeholders to ensure COVID-19 patients around the world have access to safe and effective treatments," she added.
Celltrion recognise the critical importance for new treatments in Australia to prevent serious outcomes associated with COVID-19, and are committed to bringing Regkirona to Australian patients as quickly as possible.
-----Ends-----
