Celltrion announced on the 25th that the European Medicines Agency (EMA) has begun a rolling review of the Corona 19 antibody treatment Rekirona and has begun a formal review process for product approval in Europe.
EMA’s Rolling Review is a system used by the EMA 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 controls, 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.
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. Recently, a specific discussion has been brought with the 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 completed production for 100,000 people, and plans to additionally produce 1.5 to 3 million Rekkirona annually depending on demand to respond to immediate supply.
In order to cope with the mutant virus that may occur in the future, we spurred the preparation of a response platform and started to develop a cocktail treatment that combines the candidate antibody No. 32 and Rekyrona, which showed neutralizing ability against mutant in the UK and South Africa.
Celltrion is conducting phase 3 clinical trials for 1,200 mild and moderate corona19 patients in 10 countries around the world, and plans to additionally secure the safety and effectiveness of Rekkirona through a wide range of patients.
A Celltrion official said, “Since obtaining 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 the approval process for European supply has also been in earnest through the launch of EMA’s rolling review.”
He said, “As preliminary consultations are underway with major countries in the world, we will do our best to provide early Rekirona to end the global pandemic by submitting various data and documents requested by regulatory agencies without any problems.” . Ⓒ Safe Times
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