South Korean pharmaceutical giant Celltrion is pushing for a broader use of its COVID-19 treament, Regkirona, both here and abroad. Presently, Regkirona, or CT-P59, is allowed to be used on patients with severe symptoms or high risk groups with mild symptoms only.
The company said Wednesday that it has asked the Ministry of Food and Drug Safety for permission to use on COVID-19 patients aged over 12, with mild or severe symptoms.
Celltrion said it has filed clinical data from its phase 3 clinical study to the ministry, which shows safety and efficacy of Regkirona in treating patients with a broad age range.
Celltrion has also embarked on an authorization procedure for Regkirona in Australia, which can potentially broaden the company’s patient reach further.
On Tuesday, Celltrion won approval for phase 1 clinical trial of its inhalable form of Regkirona from Australia‘s Therapeutic Goods Administration.
The trial will involve 24 healthy people, while the next phase trial will start later this year to test the efficacy of the treatment, Celltrion said.
The company added it aims to market the inhalable form of treatment for use not only in COVID-19 patients but also asymptomatic patients who had close contact with those infected.
Celltrion has been working with Inhalon Biopharma to develop an inhalable form of Regkirona since July last year.
Meanwhile, Regkirona is currently under rolling review by the European Medicines Agency. Celltrion is in talks with the US Food and Drug Administration for Emergency Use Authorization of its COVID-19 treatment as well.
Other countries that the company filed for Regkirona’s approval include Saudi Arabia, the UAE, Jordan, Iraq, and Morocco.
In July, Celltrion’s Regkirona received an emergency use authorization from the Indonesian government.
By Shim Woo-hyun (firstname.lastname@example.org