[ad_1]
Celltrion ‘Rekironaju’ Corona 19 Antibody Treatment. Celltrion provided
Antibody treatment for novel coronavirus infection developed by Celltrion (COVID-19, Corona 19) ‘Rekironaju’ is a condition to submit the results of phase 3 clinical trials to the Central Pharmacy Review Committee of the Ministry of Security of Food and Medicines held in the afternoon of the 27. Permission was advised. However, because it is difficult to draw conclusions about the clinical implications for mild patients, it was recommended for use in moderately ill patients and high-risk patients with mild symptoms.
The Ministry of Food and Drug Safety announced that it held the ‘Central Pharmacy Review Committee’ at the Food and Drug Administration headquarters in Osong, Chungbuk on the 27th at 2pm on the 27th to consult the safety and effectiveness of the celltrion antibody treatment ‘Rekironaju’. The Ministry of Food and Drug Safety is planning to make a final decision on whether to allow Rekkirona status through the ‘Final Inspection Committee’ combining expert opinions and recommendations.
This meeting of the central pharmacy review committee is a special subcommittee for biopharmaceutical safety and efficacy, 12 permanent members of the Biopharmaceutical Subcommittee, 5 verification advisory members, 1 expert recommended by the Korean Medical Association, and 18 external experts and the Ministry of Security. of Food and Medicines. Six members of the biotherapy review team from ‘Crown Crisis Response Support Headquarters 19’ attended.
On this day, the Central Pharmacists Review Committee reviewed the safety and effectiveness of the data submitted for the Rekkirona product permit application, the domestic corona outbreak, patient access to COVID-19 treatment, and the option of medical personnel to conduct a clinical examination. It was recommended to approve the product subject to submission of the Phase 3 trial results.
However, the Ministry of Food and Drug Safety said: “Contrary to the opinion of the previous verification advisory group, it was difficult to conclude the clinical importance of patients with mild symptoms, so it was recommended to use this drug in a limited group of patients. “It was recommended to administer it.”
The clinical symptoms of mild and moderate high risk Corona19 adults (18 years of age or older) as revealed by the Central Pharmacy Review Committee are those with an oxygen saturation greater than 94% in indoor air, those who do not need supplemental oxygen and before administration 7 Those who develop symptoms in one day.
The Ministry of Food and Drug Safety also reviewed the safety-related submission data and revealed that no serious life-threatening adverse events occurred, but that a phase 3 clinical trial and continuous safety assessment after marketing were necessary for a sufficient number of patients. Also, in the case of some of the committee members, with some comments, they said they suggested using a special manufacturing approval instead of a pharmaceutical product approval.
[ad_2]
