Celltrion said on the 26th (local time) that the European Medicines Agency (EMA) presented an opinion recommending the use of the Corona 19 antibody treatment’Rekirona’ before official approval. This allows European countries to prescribe Rekirona based on EMA’s recommendations for use on the day before official approval is issued.
From the beginning of this month, EMA has begun a review process to present expert opinion so that individual European national quarantine authorities, who are urgently in need of using COVID-19 treatment before EMA item approval, can make a decision to introduce Rekkirona through the’Compassionate Use Program’. Accordingly, a group of experts under the EMA’s Drug User Advisory Committee (CHMP) reviewed the quality, nonclinical and clinical data of Rekirona submitted by Celltrion. As a result, the decision was made because it was judged that the administration of Rekirona to high-risk COVID-19 patients, who are likely to be hospitalized, could lower the severe development rate and reduce the hospitalization rate.
Celltrion said that it is already conducting preliminary consultations with individual European countries for rapid global supply of Rekkirona. Based on this result, it is expected that Rekkirona’s global supply will accelerate. Celltrion is also in negotiations with the US Food and Drug Administration (FDA) and major regulators of the Organization for Economic Cooperation and Development (OECD) to obtain a Rekirona license. Celltrion has already finished producing treatments for 100,000 people last year, and plans to respond to immediate supply by additionally producing 1.5 to 3 million people of Rekirona per year depending on global demand.
Apart from this recommendation for use by country, EMA is also proceeding with a’Rolling Review’ procedure for a preliminary review before official item approval from February 24 (local time). Celltrion has already submitted quality and manufacturing process control, non-clinical and clinical trial data required for rolling review to EMA for rapid approval of Rekirona’s items, and CHMP has already submitted the efficacy and safety of Rekirona based on various data submitted by Celltrion. Evaluate is in progress
Meanwhile, the CHMP recommended that Remsima SC also approve an application for permission to change Remsima SC for indications for rheumatoid arthritis (RA), allowing immediate administration of Remsima intravenous (IV) dosage forms without pre-dosing. Until now, Remsima SC was only available after at least two doses of the IV formulation.
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.” .
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