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Central Committee conflicted over Rekirona limits use

By Lee, Tak-Sun | translator Byun Kyung A

21.02.18 12:18:46

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Some opposed of conditional approval, ¡°Need to revisit after Phase III¡±

Celltrion ¡°Meaningful to have shortened the time to recovery in mild condition patients¡±


Apparently, the Central Pharmaceutical Affairs Deliberation Committee has reached a conclusion after an intense discussion in approving of Celltrion¡¯s COVID-19 monoclonal antibody treatment Rekirona, conditionally authorized for use on Feb. 5.

The Central Pharmaceutical Affairs Deliberation Committee was convened for a meeting on Jan. 27 and advised Rekirona to be conditionally used on high-risk patients with mild COVID-19 symptoms and patients with moderate symptoms. The indication was actually narrowed from the COVID-19 Treatment Advisory Panel¡¯s previously opinion that the treatment can be used without a limitation in patients with mild to moderate symptoms.

In the Central Committ

Lee, Tak-Sun(hooggasi2@dailypharm.com)
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