[의학신문·일간보사=김민지 기자] Celltrion is the European Medicines Agency (hereinafter referred to as EMA), Corona 19 antibody treatment Rekirona (development name: CT-P59, ingredient name: Regdanbimab)<사진>On the 25th, it announced on the 25th that the’Rolling Review’ of’Rolling Review’ has begun and the formal review process for product approval in Europe has begun.
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EMA’s Rolling Review is a system used by the EMA-affiliated Drug User Advisory Committee (CHMP) to accelerate the evaluation of promising treatments or vaccines in crisis situations such as pandemics. It is a method of receiving data and documents on the efficacy, safety, and quality of drugs in real time before the final approval application and reviewing them quickly.
Celltrion has submitted quality and manufacturing process control, non-clinical and clinical trial data to EMA for rapid global approval of Rekirona. CHMP begins evaluating the efficacy and safety of Rekirona based on various data submitted by Celltrion.
After the completion of Rekkirona’s global phase 2 clinical trial, the company has conducted preliminary consultations with major global regulatory agencies such as the European EMA and the US FDA (Food and Drug Administration) to proceed with the rapid approval process. In particular, in recent years, there has been a specific discussion with the EMA for initiating a rolling review.
Celltrion is also making progress in securing quantities for smooth supply immediately after completing the global rapid approval process. It has already completed production for 100,000 people, and plans to additionally produce 1,500,000 to 3 million people per year, depending on demand, to respond to immediate supply.
A Celltrion official said, “Since we obtained the conditional item license from the Ministry of Food and Drug Safety in early February of this year, we have been supplying Rekyrona to domestic medical institutions smoothly, and through the launch of EMA’s rolling review, the approval process for European supply has also been in earnest.” “As preliminary consultations are underway with major countries in the world, we will do our best to provide early supply of Rekkirona to end the global pendemic by submitting various data and documents requested by each country’s regulatory agencies without disruption.
Reporter Minji Kim [email protected]
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