The Ministry of Food and Drug Safety approved CT-P59 under its patient treatment scheme on Friday, its website showed.
Under the scheme, patients with life-threatening conditions and with no other means of treatment can receive drugs still undergoing clinical trials, the ministry said.
Celltrion is conducting second- and third-phase clinical trials for CT-P59, and plans to seek emergency-use approval for the treatment before year-end, a company spokesperson said.
The treatment is expected to be administered to the first patients “soon”, Korea Disease Control and Prevention Agency official Kwon Jun-wook said in a briefing on Tuesday.
South Korea Celltrion's candidate Covid-19 drug gets approval for special-case use
Image: 123rf/Monchai Tudsamalee
Doctors can administer South Korean pharmaceutical maker Celltrion Inc's candidate Covid-19 antibody treatment to patients with life-threatening conditions, health authorities said on Tuesday.
The Ministry of Food and Drug Safety approved CT-P59 under its patient treatment scheme on Friday, its website showed.
Under the scheme, patients with life-threatening conditions and with no other means of treatment can receive drugs still undergoing clinical trials, the ministry said.
Celltrion is conducting second- and third-phase clinical trials for CT-P59, and plans to seek emergency-use approval for the treatment before year-end, a company spokesperson said.
The treatment is expected to be administered to the first patients “soon”, Korea Disease Control and Prevention Agency official Kwon Jun-wook said in a briefing on Tuesday.
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