SEOUL, 05 Feb. (Yonhap) – The Ministry of Food and Drug Safety announced on Friday that it had approved the candidate for Covid-19 treatment from pharmaceutical giant Celltrion Inc. under several conditions.
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The conditional marketing authorization for CT-P59, a candidate for treatment with anti-Covid-19 monoclonal antibody, marks the country’s first treatment against the novel coronavirus.
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The ministry said CT-P59 could be given to patients with Covid-19 at higher risk, referring to people aged 60 or older, or suffering from health conditions such as heart disease, diabetes, hypertension or chronic diseases that affect the respiratory system.
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The department also announced the approval on the condition that Celltrion submit the results of the Phase 3 global clinical trial.
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Last month, Celltrion announced the first results of its randomized, placebo-controlled, global Phase 2 clinical study, claiming that CT-P59 reduces recovery time and the risk of developing a severe case.
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Celltrion plans to conduct a global Phase 3 clinical trial, an essential part of the study, in more than 10 countries to obtain more comprehensive results on the safety and efficacy of CT-P59.
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The company also plans to submit an emergency use authorization request to the United States Food and Drug Administration (FDA) and conditional marketing authorization to the European Medicines Agency (EMA). In the coming months.
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CT-P59 comes as an intravenous injection that is injected directly into the vein over 90 minutes.
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