[사회]”Celltrion antibody treatment can be approved under the premise of phase 3 clinical trial…

[앵커]

About Celltrion’s COVID-19 antibody treatment, the Central Pharmacist Review Committee, an advisory body of the Ministry of Food and Drug Safety, gave an opinion that “can be approved under the premise of a phase 3 clinical trial.”

However, while the verification advisory group previously recommended that it can be administered to adult patients with mild and moderate corona19, the Central Pharmacopoeia said that the scope of patients with mild symptoms should be further limited.

Reporter Seungjae Kim reports.

[기자]

The Ministry of Food and Drug Safety held the Central Pharmacy Review Committee yesterday (27th) to receive expert advice on the safety and effectiveness of Celltrion’s COVID-19 antibody treatment, Rekirona.

The Central Pharmacopoeia concluded that the KFDA could approve the item subject to submission of the results of the phase 3 clinical trial.

This is in the same context as the’Corona 19 Treatment and Vaccine Safety and Effectiveness Verification Advisory Group’, the first expert advisory, recommended that the item be approved on the premise of conducting phase 3 clinical trials.

However, contrary to the opinion of the previous verification advisory group, the Central Pharmacopoeia recommended that the group of patients administered should be limited as it is difficult to draw conclusions on the clinical implications of Rekirona for mild patients.

[오일환 / 중앙약사심의위원회 위원장 : 경증환자에 대한 이 약 투여의 임상적 의미는 결론을 내리기가 어려우며 일부 제한된 환자군에서 사용하는 것을 권고하였습니다.]

Previously, the Verification Advisory Group saw that it is acceptable to administer Rekirona to adult patients with mild and moderate Corona19, but the Central Pharmacopoeia believes that the scope of mild patients should be further limited.

Accordingly, the Central Pharmacopoeia recommended that it be administered to patients with mild and moderate symptoms in high-risk groups.

In addition, he explained that oxygen saturation in indoor air exceeds 94%, no supplemental oxygen supply is required, and all three conditions for symptoms to develop within 7 days prior to administration must be met.

The Ministry of Food and Drug Safety will decide whether to approve the state of Rekirona at the final inspection committee, the last expert advisory procedure.

ytn This is Seungjae Kim.

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