TGA grants provisional approval for Celltrion's regdanvimab

Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval for the use of regdanvimab (trade named Regkirona) in adult patients with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

The approval was granted to the Australian subsidiary of South Korea’s Celltrion Healthcare (Kosdaq: 068270).

Monoclonal antibodies are proteins designed to attach to a specific target, in this case the spike protein of SARS-CoV-2, which works to block the path the virus uses to enter human cells. The TGA's decision is based on the efficacy and safety data in the global Phase III clinical trial involving more than 1,315 people in 13 countries including the USA, Spain and Romania. Data showed regdanvimab reduced the risk of COVID-19 hospitalization by 72% for patients at high-risk of progressing to severe COVID-19 and shorted the time for improving clinical symptoms by more than 4.7 days.