Celltrion's CT-P59 approved for limited Covid treatment
A Celltrion Covid-19 treatment candidate was approved for individual use on patients who have experienced little benefit from authorized treatments.
Kwon Joon-wook, deputy director of the Korea Disease Control and Prevention Agency (KDCA), said in a press briefing Tuesday that Celltrion’s CT-P59 received a nod from the Ministry of Food and Drug Safety on Dec. 11 to be offered as treatments on an individual basis.
As such, the antibody treatment will be offered to a severe symptom patient at Asan Medical Center in Seoul. Injections have not yet started, according to Kwon.
This would be the first time Celltrion’s CT-P59 would be provided as a treatment and not for clinical trial purposes.
Korea’s Ministry of Food and Drug Safety permits emergency use of unlicensed treatments for individual clinical cases. The request has to be made by the patient’s doctor upon judgement that the unauthorized drug is the only option.
The approval is different from the emergency use authorization granted at the national level, which would allow widespread use of the drug candidate. Celltrion aims to submit documents for that authorization this year. CT-P59 is currently undergoing Phase 2 clinical trials on severe symptom patients in Korea.
BY SONG KYOUNG-SON [firstname.lastname@example.org]
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