The Ministry of Food and Drug Safety issued a recommendation for Celltrion's antibody therapy Regkirona to treat moderate patients and mild symptoms in high-risk groups at a pharmaceutical advisory committee meeting on Wednesday.

The Ministry of Food and Drug Safety’s advisory committee has recommended Celltrion’s Covid-19 therapy, Regkirona, for treating moderate patients and the high-risk group with mild symptoms.
The Ministry of Food and Drug Safety’s advisory committee has recommended Celltrion’s Covid-19 therapy, Regkirona, for treating moderate patients and the high-risk group with mild symptoms.

At the meeting, Professor Oh Il-hoan of the Catholic University of Korea's Medical School, who doubles as the head of the review board, said that the ministry could authorize the use of Regkirona after Celltrion submits the phase 3 clinical study results.

Professor Oh added that the committee agreed on the need for Regkirona to treat Covid-19 patients, considering patient's access to the drug and treatment option after reviewing the safety and efficacy profile.

"When the committee members opposed to the first advisory decision, however, we believed that more data is necessary to conclude the clinical significance in administrating Regkirona on mild patients. So, we recommend using it in moderate and mild patients with high risks."

The panel expects Rekirona to improve adult patients' symptoms who do not require auxiliary oxygen supply and have higher oxygen saturation than 94 percent and developed symptoms within a week before the administration, Oh said.

Lee Dong-hee, director-general of the National Institute of Food and Drug Safety Evaluation, said, "There were no significant life-threatening abnormal cases reported in Celltrion's data, but the ministry needs to review the results of more patients and conduct a consistent evaluation on safety after giving a conditional approval."

Regarding the preventive effect of Regkirona, Lee said that the ministry would make the final decision after reviewing the results of phase 3 clinical trial.

For drugs that are subject to special review, such as Regkirona, where a company faces difficulty in preparing data for approval or has insufficient information, the commissioner of the Korea Disease Control and Prevention Agency can send a proposal for authorization to the regulator on special occasions permitted based on the Pharmaceutical Acts.

The ministry plans to decide whether to give full authorization for Rekkirona at the final advisory meeting.

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