[의학신문·일간보사=김민지 기자] Celltrion, the European Medicines Agency (hereinafter referred to as EMA) on the 2nd of the local time, announced that Corona 19 antibody treatment Rekirona (development name: CT-P59, ingredient name: Regdanvimab)<사진> It announced on the 3rd that it has begun a review process to present expert opinions to European countries that want to be introduced early.
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This review is a separate procedure from the Rolling Review, which began on the 24th of last month (local time). Program)’, etc., a group of experts affiliated with the Drug User Advisory Committee (CHMP) under the EMA will present scientific opinions on whether or not Rekirona can be used.
This review is based on Celltrion’s clinical data for patients with moderate corona19 disease and high-risk patients who are at high risk for hospitalization. EMA plans to verify whether Rekirona can reduce the rate of severe development as a treatment for COVID-19 and reduce the rate of visits and hospitalizations in intensive care facilities.
Meanwhile, Celltrion has already submitted quality and manufacturing process control, non-clinical and clinical trial data to EMA in order to proceed with the rapid approval of Rekirona through’Rolling Review’. From the 24th of last month, CHMP started to evaluate the efficacy and safety of Rekirona based on various data submitted by Celltrion.
Reporter Minji Kim [email protected]
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