Celltrion's COVID-19 Antibody Treatment Regkirona Receives Conditional Approval in Australia

[Asia Economy Reporter Buaeri] Celltrion announced on the 7th that its COVID-19 antibody treatment, Rekkeulona (generic name Regdanvimab), has received conditional approval from the Australian Therapeutic Goods Administration (TGA).

According to Celltrion, the Australian TGA granted provisional registration for Rekkeulona under the expedited provisional approval process for adult high-risk mild and moderate COVID-19 patients. This measure corresponds to conditional approval under other countries' standards.

Rekkeulona's safety and efficacy were confirmed in a global Phase 3 clinical trial involving 1,315 mild to moderate COVID-19 patients across 13 countries worldwide, including South Korea, the United States, Spain, and Romania.

A Celltrion official stated, "Based on the safety and efficacy proven in the global clinical trials of Rekkeulona, we have obtained conditional approval status for use as a treatment from the Australian health authorities," adding, "We will do our best to contribute to preventing the spread of COVID-19 in Australia as well."

Rekkeulona received conditional approval from the South Korean Ministry of Food and Drug Safety in February and obtained full product approval in September, and is currently in use. Last month, it also received full product approval from the European Commission (EC).

This content was produced with the assistance of AI translation services.