Celltrion’s Corona 19 antibody treatment’Rekironaju’. Celltrion provided
Celltrion-developed novel coronavirus infection (COVID-19, Corona 19) antibody treatment’Rekironaju’ is a condition for submitting the results of phase 3 clinical trials at the Central Pharmacy Review Committee of the Ministry of Food and Drug Safety held on the afternoon of the 27th. Permission was advised. However, because it is difficult to draw conclusions about the clinical implications for mild patients, it was recommended to administer it to 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 headquarters of the Food and Drug Administration in Osong, Chungbuk on the 27th at 2 pm 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 permit the state of Rekkirona through the’Final Inspection Committee’ by combining expert opinions and recommendations.
This central pharmacy review committee meeting is held with 18 external experts including 12 standing members of the Biopharmaceutical Subcommittee, which is a specialized subcommittee for deliberation on the safety and effectiveness of biopharmaceuticals, 5 verification advisory members, and 1 expert recommended by the Korean Medical Association. Six members of the’Corona 19 Crisis Response Support Headquarters’ biotherapy review team attended.
On this day, the Central Pharmacist Review Committee reviewed the safety and effectiveness of the data submitted for the application for product permission of Rekkirona, the domestic corona outbreak, patient access to the COVID-19 treatment, and the medical staff’s option to conduct a clinical trial. It was recommended to approve the product subject to submission of the results of the phase 3 test.
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 significance of patients with mild symptoms, so it was recommended to be used in a limited group of patients.” Accordingly, “this drug is used for patients with moderate symptoms and high-risk patients. It was recommended to administer it.”
The clinical symptoms of high-risk mild and moderate Corona19 adults (over 18 years of age) identified by the Central Pharmacy Review Committee are those with oxygen saturation exceeding 94% in indoor air, those who do not need supplemental oxygen, and before administration 7 Those who develop symptoms within one day.
The Ministry of Food and Drug Safety also reviewed the safety-related submission data and found that no serious life-threatening adverse events occurred, but said that it was necessary to conduct a phase 3 clinical trial and a continuous safety evaluation after marketing for a sufficient number of patients. In addition, in the case of some of the committee members, with a few comments, they said that they suggested using special manufacturing approval rather than drug product approval.