Celltrion Antibody Treatment 'Rekkirona' Receives Conditional Approval in Switzerland

Celltrion Regkirona (Photo by Celltrion)

[Asia Economy Reporter Lee Chun-hee] Celltrion's COVID-19 antibody treatment 'Rekkirona' (generic name 'Regdanvimab') is expected to be used for patient treatment in Switzerland.

On the 14th, Celltrion announced that it had obtained a 2-year conditional approval, an 'emergency authorization,' for Rekkirona from the Swiss Agency for Therapeutic Products (Swissmedic) on the 12th (local time).

Celltrion submitted the results of the ongoing Phase 3 clinical trials and preclinical data on various variants including the Delta variant to Swissmedic. Swissmedic approved the emergency authorization for adult COVID-19 patients who tested positive, do not require supplemental oxygen, and are at high risk of progressing to severe disease. Previously, Celltrion received formal marketing authorization for Rekkirona from the Korean Ministry of Food and Drug Safety and the European Medicines Agency (EMA), and obtained conditional approval or emergency use authorization in countries such as Indonesia, Brazil, Peru, and Australia.

According to the statistics site Worldometer, as of the 12th, Switzerland's daily COVID-19 confirmed cases were around 14,761. Recently, the Omicron variant has been spreading rapidly across Europe, causing a swift increase in confirmed cases.

A Celltrion official stated, “Based on the safety and efficacy proven through global clinical data of Rekkirona, it has been officially recognized as a COVID-19 treatment by Swiss health authorities,” adding, “We will do our best to help alleviate the burden on medical sites caused by the surge in confirmed cases in Switzerland.”

Meanwhile, Celltrion is conducting additional research and development (R&D), including developing a cocktail inhalation treatment combining Rekkirona and CT-P63 to respond to the rapidly emerging COVID-19 variants. CT-P63 recently demonstrated safety in Phase 1 clinical trials, and neutralization ability against the Omicron variant was confirmed through pseudovirus neutralization tests conducted by the U.S. National Institutes of Health (NIH). The inhalation form of Rekkirona has completed patient drug administration and is currently analyzing Phase 1 clinical trial results.

Celltrion plans to initiate large-scale global clinical trials of the cocktail antibody inhalation treatment combining Rekkirona and CT-P63 within the first quarter and is consulting with major global regulatory agencies on clinical trial design.

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