[Chungbuk Ilbo] On the 25th, the European Medicines Agency (EMA) initiated a’rolling review (sequential review)’ of the Corona 19 antibody treatment Rekkirona (CT-P59, ingredient name Regdanvimab) on the 25th and officially reviewed for product approval. It said the procedure had begun.
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 already submitted quality and manufacturing process control, non-clinical and clinical trial data to EMA in order to expedite Rekirona’s rapid global approval.
CHMP begins evaluating the efficacy and safety of Rekirona based on various data submitted by Celltrion.
Celltrion has conducted preliminary consultations with major global regulatory agencies such as the European EMA and the US Food and Drug Administration (FDA) to proceed with the rapid approval process after the completion of Rekkirona’s global phase 2 clinical trial. In particular, in recent years, we have had specific discussions with EMA to initiate 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 1.5 to 3 million people per year, depending on demand, to respond to immediate supply.
In addition, in order to cope with the mutant virus that may occur in the future, it has spurred the development of a mutant response platform, and at the same time began developing a cocktail treatment that combines candidate antibody No. 32 and Rekirona, which showed neutralizing ability against mutants in the UK and South Africa. In addition, Celltrion is conducting phase 3 clinical trials targeting approximately 1,200 mild and moderate corona19 patients in 10 countries around the world. It plans to further secure the safety and efficacy of Rekirona through a wide range of patients.
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 smoothly to domestic medical institutions, and the approval process for European supply has been in earnest through the launch of EMA’s rolling review.” “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,” he said.
/ Reporter Seongjiyeon