[라이센스뉴스 김지훈 기자] Celltrion recommends that the European Medicines Agency (hereinafter EMA, European Medicines Agency) use the Corona 19 antibody treatment’Recyrona (developed name CT-P59, ingredient name Regdanvimab)’ before official product approval. He said he had provided an opinion. This allows European countries to use Rekkirona based on EMA’s recommendations for use prior to formal authorization.
From the beginning of last March, EMA is aiming to present expert opinions so that individual European national quarantine authorities in urgent need to use COVID-19 treatments before EMA product approval can make a decision to introduce Rekkirona through the’Compassionate Use Program’. Started the review process.
Accordingly, the expert group of the EMA-affiliated Drug User Advisory Committee (CHMP) reviewed the quality, non-clinical and clinical data of Rekirona submitted by Celltrion, and as a result, Rekkyro targets high-risk COVID-19 patients who are likely to be hospitalized. I made this decision because it was judged that my administration could lower the rate of severe development and reduce the rate of hospitalization.
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. Celltrion is also in consultation with the U.S. Food and Drug Administration (FDA) and major regulators of the Organization for Economic Cooperation and Development (OECD) for Recyrona approval, and is striving to secure quantities for smooth supply after completion of approval in global countries. have.
Celltrion has already completed the production of treatments for 100,000 people last year, and plans to immediately respond to supply by producing 1.5 to 3 million people of Rekirona annually 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 product 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
On the other hand, 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-medication. 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 conduct 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.