SEOUL, Feb. 5 (Korea Bizwire) — South Korea’s drug safety agency said Friday it has approved pharmaceutical giant Celltrion Inc.’s COVID-19 treatment candidate on several conditions.
The conditional marketing authorization of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate, marks the country’s first homegrown COVID-19 treatment.
The Korean Ministry of Food and Drug Safety said CT-P59 can be administered to COVID-19 patients at higher risk, referring to people aged 60 or older, or with health conditions like heart disease, diabetes, high pressure or chronic diseases that affect the respiratory system.
The ministry also announced the authorization on the condition that Celltrion submit results of the global phase-three clinical trial.
Last month, Celltrion announced top-line results from its randomized and placebo controlled global phase-two clinical study, saying CT-P59 reduces recovery time and the chance of a severe case.
Celltrion plans to conduct a global phase-three clinical trial, a pivotal part of the study, in more than 10 countries to obtain more comprehensive safety and efficacy results of CT-P59.
The company also plans to submit an application for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration and for Conditional Marketing Authorization to the European Medicines Agency (EMA) in the coming months.
CT-P59 takes the form of an intravenous injection that is directly injected into the vein for 90 minutes.