Celltrion COVID-19 Treatment Receives 'Conditional Approval Recommendation' from MFDS Central Pharmaceutical Committee (Comprehensive)

"Comprehensive Consideration of Safety, Effectiveness, Domestic Epidemic Status, and Patient Accessibility"

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[Asia Economy Reporter Kim Ji-hee] The Central Pharmaceutical Affairs Deliberation Committee has issued an advisory recommending the administration of Celltrion's novel coronavirus disease (COVID-19) antibody treatment 'Rekkironaju' to patients with moderate symptoms and high-risk mild patients.

The Ministry of Food and Drug Safety (MFDS) announced on the 27th that after holding a Central Pharmaceutical Affairs Deliberation Committee meeting at the Osong headquarters in Chungbuk from 2 p.m. to discuss the safety and efficacy of Rekkironaju, this opinion was reached. The Central Pharmaceutical Affairs advisory is the second stage of the external expert consultation process for COVID-19 treatment drug approval review, which the MFDS has established in a 'triple' system. The meeting was attended by 18 external experts, including 12 standing members of the Biopharmaceutical Subcommittee, which specializes in the safety and efficacy review of biopharmaceuticals, 5 verification advisory members, and 1 expert recommended by the Korean Medical Association, as well as 6 members of the MFDS's 'COVID-19 Crisis Response Support Headquarters' Biotherapeutics Review Team.

Oh Il-hwan, chairman of the Central Pharmaceutical Affairs Deliberation Committee, said at a briefing after the meeting, "It was advised that Rekkironaju is recognized as necessary for domestic patients and that approval could be granted on the condition of submitting phase 3 clinical trial results." He added, "We reviewed the data submitted by Celltrion and, based on the safety and efficacy results from that data, as well as considering the domestic COVID-19 pandemic situation, patient access to treatments, and medical professionals' choice, we reached this conclusion."

However, the Central Pharmaceutical Affairs Deliberation Committee expressed a different opinion from the previous verification advisory group regarding mild patients. Since it is difficult to conclude the clinical significance of administration to mild patients, it recommended use only in some limited patient groups. Chairman Oh explained, "Considering the results of the submitted phase 2 clinical trial comprehensively, the statistical verification method was not established at the start of the initial clinical trial for mild patients, and an adequate number of patients was not secured, so statistically significant therapeutic effects could not be confirmed." He added, "This limitation is interpreted as something that can be verified through a larger patient population and more precise clinical design." He further stated, "We recommended administration to moderate patients and high-risk mild patients."

The Central Pharmaceutical Affairs Deliberation Committee's recommended administration criteria are: ▲ those with oxygen saturation exceeding 94% in indoor air ▲ those who do not require supplemental oxygen ▲ those whose symptoms appeared within 7 days before administration. All three conditions must be met.

Regarding the recommendation for conditional approval despite the difficulty in concluding the clinical significance of administration to mild patients, the committee responded, "This recommendation was made to provide medical professionals with the option to use the treatment in cases where mild patients are in high-risk groups or where very serious side effects are expected."

Meanwhile, the MFDS is reviewing some quality data related to Rekkironaju and other submitted review materials, and will comprehensively consider expert opinions obtained from the previous verification advisory group and the Central Pharmaceutical Affairs Deliberation Committee, as well as efficacy and effect drafts and recommendations, to make a final decision on approval at the 'Final Inspection Committee.'