SEOUL -- Celltrion has applied for state permission to expand the use of its COVID-19 antibody treatment, Regkirona, from a high-risk group of people to those over the age of 12 with mild or moderate symptoms. South Korea's drug safety agency pledged a quick and close examination to approve the biotech company's application as the number of patients increases despite strengthened sanitary steps.
Celltrion wants to change the use of its antibody treatment code-named CT-P59 (regdanvimab) and shorten administration time from 90 minutes to 60 minutes, based on phase 3 clinical trials involving 1,315 people in 13 countries. "We will do our best to quickly supply safe and effective treatments to our people," the Ministry of Food and Drug Safety said in a statement on August 11.
CT-P59 has been approved in South Korea and other countries as an intravenous injection for COVID-19 patients, but its administration is limited to patients with mild or moderate symptoms in a high-risk group of people who are over 60 or have at least one of cardiovascular disease, chronic respiratory disease, diabetes or high blood pressure.
The ministry's earlier permission was conditional, asking Celltrion to submit the results of third-stage clinical trials. CT-P59 is directly injected into the vein for 90 minutes. Celltrion has said that CT-P59 shortens the recovery time of patients and protects patients with mild symptoms from developing into severe cases.
CT-P59 has been developed through a process of extracting a neutralizing gene and recombining it into host cells that can be mass-produced. Celltrion's U.S. partner, Inhalon Biopharma, has secured permission from the Therapeutic Goods Administration, a regulatory agency in Australia, to test the efficacy of CT-P59's inhalation type. Celltrion said in a statement on August 9 that the scope of application would be expanded through clinical trials of patients with no symptoms and those in close contact with virus carriers.
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