Celltrion announced on the 3rd that the European Medicines Agency (EMA) has entered into a review of emergency use by individual countries before the approval of the novel coronavirus infectious disease (Corona 19) antibody treatment’Rekkirona’ (ingredient name Legdanvimab CT-P59, photo).
The purpose of this review, which began on the 2nd (hereinafter referred to as local time), is to allow individual European national quarantine authorities in urgent need of treatment to make a decision to introduce them even before EMA’s approval of the item. This is a procedure in which an expert group belonging to the Drug User Advisory Committee (CHMP) under EMA evaluates the efficacy and safety of Rekirona and presents scientific opinions on whether it can be used. To this end, the expert group is evaluating the clinical data of Celltrion, which was conducted in patients with moderate corona19 and high-risk patients who are at high risk of progressing to hospitalization. Through this, it is a plan to verify whether Rekkirona can reduce the rate of severe COVID-19 development and decrease the rate of visits and hospitalizations in intensive care facilities.
Separately, EMA initiated a rolling review (Rolling Review) to decide whether to introduce Corona 19 drugs before applying for approval by reviewing Corona 19 drugs faster than before from the 24th of last month. Accordingly, Celltrion is evaluating the quality and manufacturing process management, nonclinical and clinical trial data submitted by Celltrion.
Celltrion has already produced 100,000 servings, and plans to add 1.5 to 3 million units per year depending on the demand, so he is confident that it will be able to supply Rekkirona smoothly immediately after global approval.
Reporter Kim Hyun-joo firstname.lastname@example.org
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