Central Pharmaceutical Review Committee Recommends Conditional Approval of Rekkiro-na Injection... "Restricted to High-Risk Groups" (Update)

"Clinical Significance of Administering Regkirona in Mild Patients Difficult to Conclude"

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[Asia Economy Reporter Kim Ji-hee] The Central Pharmaceutical Affairs Deliberation Committee has expressed the opinion that Celltrion's novel coronavirus (COVID-19) antibody treatment 'Rekkironaju' can be approved on the condition that Phase 3 clinical trial results are submitted. However, the committee recommended that Rekkironaju be used in a limited patient group, such as patients with moderate symptoms and high-risk mild patients.

The Ministry of Food and Drug Safety announced on the 27th at 2 p.m. at its headquarters in Osong, Chungbuk, that this opinion was reached following the Central Pharmaceutical Affairs Deliberation Committee's consultation on the safety and efficacy of Rekkironaju. The committee's consultation is the second stage of the Ministry's 'triple' external expert advisory process for COVID-19 treatment drug approval review.

However, unlike the previous verification advisory group's opinion, the committee found it difficult to conclude the clinical significance of administering this drug to mild patients and thus recommended its use in some limited patient groups. This means that Rekkironaju should be administered to patients with moderate symptoms and high-risk mild patients.

Furthermore, regarding safety after administering Rekkironaju, based on the data submitted by the company, no serious adverse events have occurred at the current level, but it is necessary to conduct Phase 3 clinical trials with a sufficient number of patients and continuous post-marketing safety evaluations in the future.

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