Celltrion Submits Formal Application for European Marketing Authorization of 'Rekkirona'

Celltrion COVID-19 Antibody Treatment 'Rekkirona' (Photo by Celltrion)

[Asia Economy Reporter Lee Chun-hee] Celltrion's COVID-19 antibody treatment 'Rekkirona' (generic name 'Regdanvimab') is set to pursue formal marketing authorization in Europe.

On the 1st (local time), Celltrion announced on the 5th that it had applied for formal marketing authorization (MAA) of Rekkirona to the European Medicines Agency (EMA). The indication target is adult patients aged 18 and over confirmed with COVID-19 who do not require supplemental oxygen and are at high risk of progressing to severe disease.

Celltrion submitted the final formal marketing authorization seven months after the EMA rolling review (a pre-authorization evaluation process) of Rekkirona began at the end of February. Considering the COVID-19 pandemic, EMA exceptionally initiated the rolling review for Rekkirona, which was still in clinical trials at the time, and has been conducting the evaluation since then. During this process, EMA found the various data submitted by Celltrion sufficient to proceed with the formal authorization process and requested Celltrion to submit the formal marketing authorization documents. Celltrion expects that the formal marketing authorization will be granted early, as EMA has thoroughly verified the data through the rolling review.

Rekkirona secured safety and efficacy in a global Phase 3 clinical trial involving 1,315 patients with mild to moderate COVID-19 conducted in 13 countries including Korea, the United States, and Spain. Following conditional approval from the Korean Ministry of Food and Drug Safety in February, Rekkirona received formal marketing authorization last month. According to the Korea Disease Control and Prevention Agency, as of the 29th of last month, it has been administered to 16,862 patients at 114 hospitals.

A Celltrion official stated, "Following formal marketing authorization in Korea, we have entered the formal marketing authorization process in Europe, accelerating the global approval process. We will continue efforts to ensure early supply so that Rekkirona can be actively used for high-risk patients worldwide who need antibody treatment."

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