[칼럼] Decision made after three-fold consultation with the Ministry of Food and Drug Safety Celltrion Rekirona State: Jeong Pil 正筆

The Ministry of Food and Drug Safety is a treatment for Celltrion Rekirona ‘3medium’ Domestic production as determined after consulting 1Arc corona19 Celltrion in that it has a cure ‘Rekirona Province’ With permission 3Award data submission conditional, High risk group mild·While limited to moderate, Celltrion’s‘Rekirona Province’(Ingredient name,Legdanbimab·CT-P59)Korea’s first corona19 Licensed as a cure. The administration target is corona19 High-risk, mild and moderate adult patients.. Ministry of Food and Drug Safety 5Within days·Final inspection committee consisting of external experts is held, Celltrion last year 12month 29Corona applied for work permit19 Antibody therapy ‘Rekirona Province960mg (Legdanbimab)’About 3It was revealed that the approval was decided on condition of submission of the results of the phase clinical trial..

The meeting on this day is Corona19 The Food and Drug Administration 3As the last step of consulting, External experts including Yu-hwan, Chairman of the Biological Drug Subcommittee, Central Pharmacy Review Committee 3Inside the KFDA such as Myeongwa 5People attended. The final inspection committee comprehensively reviewed the review results of the Ministry of Food and Drug Safety and the contents of the previous two consultations., According to the advisory opinion of the Central Pharmacy Review Committee ‘Rekirona Province’About 3It was decided to approve the item subject to the submission of the results of the phase clinical trial.. The final review committee will be conducted for non-clinical trials including clinical trials., quality, Risk management plan, Produce·Quality control, etc..

The main data necessary for this permit review have been faithfully submitted., safety·As a result of in-depth review of each field related to effectiveness and the results of on-site surveys, it was determined that there was no problem with the product approval.. The final review committee respected the results of consultations from the verification advisory group and the central pharmacist review committee and finally decided on the range of use of this drug from mild to moderate adult patients in high-risk groups.. Food and Drug Administration “Corona developed in Korea for the first time by focusing all capabilities and thoroughly verifying safety and effectiveness19 Officially approved for neutralizing antibody therapy.”And “after 3We plan to manage the phase clinical trial so that it can be faithfully progressed..

Of course, we will conduct thorough monitoring of side effects during use and cooperate with relevant ministries so that they can be safely used for patients who are indispensable in the clinical field.”Said. ‘Rekirona Province’The corona19 Selecting the neutralizing antibody gene present in the blood of the cure and inserting this gene into host cells capable of mass production(Recombination)It is a gene-recombinant neutralizing antibody therapy produced in large quantities through cell culture.. The efficacy of this drug·The effect is high risk group, mild to moderate adult(18Older than) Improving the patient’s clinical symptoms,, usage·Dose is adult weight 1kg Per this drug 40mgof 90minute(±15minute)Injected into the liver vein.

together ‘High risk group’silver 60Age or older or an underlying disease(Cardiovascular disease, Chronic respiratory disease, diabetes, One or more of high blood pressure)Refers to a group with. ‘Rekirona Province’Is the first domestically developed drug to be approved.19 Corona is the world’s third cure and validated by regulatory authorities19 Antibody therapy. With this permission ‘Rekirona Province’Corona19 In a pandemic situation, when used in a medical field that requires treatment,, Coronavirus with vaccine to be used in Korea in the future19It is expected to play a meaningful role in overcoming problems and returning to daily life..

Also, This medicine 3If a clear effect is confirmed in the phase clinical trial, it will not only be used appropriately for patient treatment, but also·It seems that it can help to alleviate the difficulty of securing critically ill beds in the medical field.. Food and Drug Administration is Corona19 In order to secure expertise and objectivity in the treatment approval process ‘Pharmaceutical Affairs Law’The legal advisory body of the Ministry of Food and Drug Safety in accordance with ‘Central Pharmacy Review Committee’In addition to ‘corona19 remedy/Vaccine safety·Effectiveness verification advisory group’(Below verification advisory group)and ‘Final Inspection Committee’Additionally configure 3Went through an advisory procedure.

In addition, the Ministry of Food and Drug Safety 17Work ‘Rekirona Province’ We received advice from the verification advisory group on whether the clinical trial results were appropriate for acknowledging the therapeutic effect of this drug and the safety of this drug.. Followed by last month 27Work ‘Rekirona Province’About 3It is considered to be of great significance in that it received advice from the Central Pharmacy Review Committee on whether it is appropriate to acknowledge safety and effectiveness under the condition of submitting the results of the phase clinical trial after marketing..

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