Celltrion receives conditional approval for CT-P59
The Ministry of Food and Drug Safety granted conditional approval for Celltrion to market its Covid-19 treatment, but only to patients with mild to moderate symptoms.
The conditional marketing authorization for CT-P59 is the first for a Korea-developed Covid-19 treatment, and the third in total.
The advisory board of the Ministry of Food and Drug Safety officials and outside experts said on Friday it granted approval to market the treatment on condition that the pharmaceutical company submits the results of its third trial.
Celltrion initiated the third clinical trial last month. It could not confirm when the third trial will be complete.
Celltrion said CT-P59 treated patients reported “a significantly shortened time to clinical recovery ranging from 3.4 to 6.4 days quicker compared to the placebo.”
The panel said the treatment improves the condition of patients aged above 18 suffering mild to moderate symptoms, but not for those in a severe condition.
Forty milligrams of the treatment per kilo of a patient’s weight is administered over 90 minutes.
Along with the relevant data showing the treatment’s efficacy, the panel also examined the production facilities to make sure the treatment can be produced stably and consistently.
The treatment, along with the distribution of Covid-19 vaccines, will play meaningful roles in helping people “return to their daily lives,” said the ministry in a statement.
“The Ministry of Food and Drug Safety will strictly monitor any side effects shown during the use of the treatment, and discuss with relevant ministries for the treatment to be safely used to patients in need,” the ministry added.
“Celltrion’s effort over the past year has come to fruition through this conditional approval” of the treatment, the company said in a statement on Friday. The company said it will do its best for patients suffering severe symptoms that could result in death and shorten the treatment period for Covid-19 by quickly distributing CT-P59 nationwide.
Celltrion plans to submit applications for Emergency Use Authorization with the U.S. Food and Drug Administration and for Conditional Marketing Authorization to the European Medicines Agency in coming months.
Celltrion's stock closed at 341,500 won ($303) on Friday, unchanged from the previous trading day.
BY JIN MIN-JI [email@example.com]