Celltrion (CEO Woo-Sung Ki) is using the Corona 19 antibody treatment “Rekirona (developed name CT-P59, ingredient name Regdanvimab)” from the European Medicines Agency (hereinafter referred to as EMA, European Medicines Agency) before official approval It was announced on the 27th that it had presented a recommended opinion.
This allows European countries to use Rekkirona based on EMA’s recommendations for use prior to formal authorization.
Celltrion is already conducting preliminary consultations with European countries for rapid global supply of Rekirona, and based on this result, it is expected that Rekirona’s global supply will accelerate.
In addition, the US Food and Drug Administration (FDA) and the Organization for Economic Cooperation and Development (OECD) are in consultation with major regulators for the Rekkirona approval, and are also trying to secure quantities for smooth supply after completion of approval in global countries. .
In particular, it has already completed the production of treatments for 100,000 people last year, and plans to immediately respond to the supply by producing 1.5 to 3 million people of Rekirona annually depending on global demand.
In addition to this recommendation for use by country, EMA is also conducting a’Rolling Review’ procedure for preliminary review before formal item approval from February (local time). The quality and manufacturing process management, non-clinical and clinical trial data required for the rolling review were submitted to EMA, and CHMP announced that it is conducting an evaluation on the efficacy and safety of Rekirona based on various data submitted by Celltrion.
A Celltrion official said, “According to EMA’s recommendations for use, we will do our best to smoothly proceed with prior consultations with individual countries and quickly supply treatments so that European Corona19 patients can benefit from Rekirona early on.” “If Remsima SC can be administered immediately without predosing of IV formulation, it is expected that the ease of administration of RA patients in Europe will be greatly improved,” he said.
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