Efficacy and safety evaluation… “Early supply to end the pandemic”
Celltrion has launched a’rolling review (sequential review)’ of the Corona 19 antibody treatment’Reckirona (developed name CT-P59, ingredient name Legdanvimab)’ by the European Medicines Agency (EMA), and officially reviewed for product approval in Europe. It was announced on the 25th that 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. This 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 data on quality, manufacturing process control, non-clinical and clinical trials to EMA in order to proceed with rapid global approval of Rekirona.
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, specific discussions have been made with the EMA to initiate rolling reviews.
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 Rekkirona for 1.5 to 3 million people a year depending on demand so that it can respond to immediate supply.
In addition, in order to cope with the mutant virus that may occur in the future, it spurred the establishment 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 mutant in the UK and South Africa.
In addition, Celltrion is conducting phase 3 clinical trials for about 1,200 mild and moderate corona19 patients in 10 countries around the world, and plans to additionally secure the safety and efficacy of Rekkirona 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 to domestic medical institutions smoothly, and through the launch of EMA’s rolling review, the approval process for European supply has also been in full swing. Explained.
“As preliminary consultations with major countries around the world are currently underway, we will do our best to provide early supply of Rekkirona to end the global pandemic by submitting various data and documents requested by each country’s regulatory agencies without any problems.” said.
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