EMA initiates a companion review that proceeds faster than general review
Prepared for additional production of 1.5 to 3 million people per year compared to European supply
[바이오타임즈] Celltrion’s anti-body treatment Rekyronaju (ingredient name Regdanvimab CT-P59), the’No. 1 Domestic’ Corona 19 treatment, has entered a full-scale screening process for entry into Europe.
Celltrion announced on the 25th that the European Union (EU) health authority, the European Agency for Malignant Medicine (EMA), has begun reviewing the approval of the item for the novel coronavirus infection (Corona 19) antibody treatment’Rekirona’.
Rekkironaju is a product that received conditional approval from the Ministry of Food and Drug Safety on the 5th as a’domestic No. 1’Corona 19 treatment, and has been supplied to medical institutions nationwide since the 17th in Korea. As an officially licensed antibody treatment, it is the third in the world after Eli Lilly and Regeneron in the United States.
Rekirona is a gene-recombinant neutralizing antibody treatment, which selects the neutralizing antibody gene present in the blood of a cure for Corona 19 and inserts (recombines) this gene into a host cell capable of mass production and mass-produces it through cell culture.
Celltrion completed the discovery of candidate substances, animal tests, and phases 1 and 2 clinical trials within one year, and proved the safety and effectiveness of Rekirona.
According to Celltrion, EMA has entered Rekkirona’s’Rolling Review’. Rolling Review is a review method used by the EMA’s Drug User Advisory Committee (CHMP) to quickly evaluate promising drugs or vaccines in crisis situations such as pandemics.
In general, when applying for marketing approval from EMA, all data and necessary documents on the efficacy, safety, and quality of a drug must be submitted at the initial stage of the evaluation. However, in the case of a companion review, the data of the ongoing study before the official application is entered. Review as per.
EMA is in the position that it has decided to initiate a companion review based on the initial results of an ongoing study to examine Celltrion’s ability to treat Corona 19 on Rekirona.
According to the EMA, “We have not yet evaluated the entire data set for Rekirona and it is too early to draw conclusions on the benefit-risk balance of the drug. “We will evaluate all data on the drug as possible,” he said. “The companion review will continue until sufficient evidence is available to support the application for official marketing authorization.”
However, as time was secured during the companion review period, it was expected to be faster than the general evaluation.
Celltrion has already conducted preliminary consultations with EMA and the US Food and Drug Administration (FDA) to proceed with the expedited approval process after completing phase 2 clinical trials in Rekirona. The quality, manufacturing process management, and clinical data of Rekirona state have been submitted to EMA.
Celltrion is also making progress in securing supplies in preparation for the completion of the global rapid approval process. It has already completed the production of 100,000 people, and plans to additionally produce 1.5 to 3 million lekkirona annually depending on demand so as to respond to immediate supply.
In addition, we are working hard to cope with the mutant virus that may occur in the future, such as developing a cocktail treatment that combines Rekyrona with candidate No. 32 antibody, which showed neutralizing ability in British and South African mutants.
Currently, Celltrion is conducting phase 3 clinical trials targeting about 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.
An official from Celltrion said, “The approval process for supply to Europe has been in full swing, and preliminary consultations are currently in progress with major countries in the world.” I will do my best to supply.”
Meanwhile, the news of Celltrion’s full-fledged start of the European screening for Rekkirona is on the rise. According to the Korea Exchange on the 25th, as of 12:14 p.m., Celltrion is trading at 302,000 won, up 20,000 won (7.09%) from the previous day.
Celltrion Pharmaceutical (068760), which is a related owner, is showing an increase of 7.49%, and Celltrion Healthcare (091990) is also showing an increase of 6.19%.
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