[이코노믹리뷰=황진중 기자] The European Medicines Agency (EMA)-affiliated Drug User Advisory Committee (CHMP) put it on the agenda of the meeting with the opinion of ‘recommendation for approval’ in relation to the approval of ‘Lekrona (main ingredient regdanvirab)’, a treatment for COVID-19 developed by Celltrion (068270). .
The EMA announced on the 8th (local time) that it had been placed on the agenda with an opinion to recommend approval for the COVID-19 treatment, Rekkorina, at the CHMP meeting to be held from this day to the 11th.
Lekkorna was the first antibody treatment to have a marketing authorization application submitted to the EMA. Celltrion Healthcare Hungary, in response to the EMA’s request, filed an application for marketing authorization on the 4th of last month to treat adult patients with COVID-19 who are at high risk of developing severe COVID-19.
Celltrion believes that there is a high possibility that the approval will be granted early as the EMA has sufficiently conducted the verification process for various data through a rolling review.
The EMA is in the process of evaluating the marketing approvals of major COVID-19 antibody treatments, Lekkorna and Roche and Regeneron’s ‘Lonaprev (main ingredient casiribumab + imdevimab)’. CHMP plans to hear an oral explanation on the effectiveness of lonaprev in preventing and treating COVID-19 at this meeting.
Meanwhile, CHMP is planning to give an intermediate opinion on the 4th sequential review (rolling review) of GSK/Beer’s ‘Jebudi (the active ingredient sotrovirab)’.
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