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EMA initiates a complementary review that progresses faster than the general review
Prepared for an additional production of 1.5 to 3 million people per year compared to the European supply
Celltrion announced on the 25th that the European Union (EU) health authority, the European Malignant Medicine Agency (EMA), has begun to review the approval of the article for the treatment with antibodies against the infection by the new coronavirus (Corona 19 ) ‘Rekirona’.
Rekkironaju is a product that received conditional approval from the Ministry of Food Safety and Pharmaceuticals on the 5th as Corona 19 ‘Domestic No. 1’ treatment, and has been supplied to medical institutions across the country 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 recombinant neutralizing antibody treatment that selects the blood neutralizing antibody gene for a cure for Corona 19 and inserts (recombines) this gene into a host cell capable of being mass produced and mass produced by cell culture.
Celltrion completed candidate substance discovery, animal testing, and phase 1 and 2 clinical trials in one year, and demonstrated the safety and efficacy of Rekirona.
According to Celltrion, EMA has entered Rekkirona’s ‘Rolling Review’. Rolling Review is a review method used by the EMA’s Advisory Committee on Drug Users (CHMP) to rapidly evaluate promising drugs or vaccines in crisis situations such as pandemics.
In general, when applying for EMA marketing approval, all necessary data and 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 supplemental review, the data from the ongoing study before the official application is entered.
The EMA is in the position that it has decided to initiate a complementary review based on the initial results of an ongoing study to examine the ability of Celltrion to treat Corona 19 in Rekirona.
According to the EMA, “We have not yet evaluated the entire data set for Rekirona and it is too early to draw conclusions about the benefit-risk balance of the drug. “We will evaluate as much data on the drug as possible,” he said. “The supplemental review will continue until sufficient evidence is available to support the application for an official marketing authorization.”
However, since time was obtained during the supplemental review period, it was expected to be faster than the overall assessment.
Celltrion has already held preliminary consultations with the EMA and the US Food and Drug Administration (FDA) to continue the expedited approval process after completing phase 2 clinical trials on Rekirona. The quality, manufacturing process management and clinical data for Rekirona status have been submitted to EMA.
Celltrion is also making progress in sourcing 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 produce an additional 1.5 to 3 million lekkirona annually, depending on demand, to meet immediate supply.
Furthermore, we are working hard to deal with the mutant virus that may occur in the future, such as the development of a cocktail treatment combining Rekyrona with candidate antibody No. 32, which showed neutralizing ability in British and South African mutants.
Celltrion is currently conducting phase 3 clinical trials targeting approximately 1,200 patients with mild and moderate corona19 in 10 countries around the world, and plans to further ensure the safety and efficacy of Rekkirona across a wide range of patients.
A Celltrion official said: “The approval process for the supply to Europe has been in full swing, and preliminary consultations are currently underway with the world’s major countries.” I will do my best to supply. “
Meanwhile, news about Celltrion’s full start of Rekkirona’s European projection is on the rise. According to the Korea Exchange on the 25th, at 12:14 pm, Celltrion is trading at 302,000 won, an increase of 20,000 won (7.09%) from the previous day.
Celltrion Pharmaceutical (068760), which is a related owner, is showing a 7.49% increase, and Celltrion Healthcare (091990) is also showing a 6.19% increase.
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