Celltrion is trying to push for a more expansive use for Regkirona, its COVID-19 treatment, globally. The inhalable Regkirona has only been allowed to patients over 12 years of age and on patients with severe symptoms or those are in high-risk groups with mild symptoms.
On Wednesday, Celltrion said that it has asked the Ministry of Food and Drug Safety for permission to use it on COVID-19 patients over 12 years with mild and severe symptoms.
Approval for a clinical trial in Australia
Celltrion has further said that it has received approval from Australia’s Therapeutic Goods Administration (TGA) for phase one of the inhalable Regkirona. Twenty-four healthy people will be under trial in the first phase, and the next one will begin later this year.
Earlier, Celltrion had filed clinical data from its phase 3 study on the safety and efficacy of the drug on a broad range of age groups.
This version of Regkirona is going to be inhalable
Since July last year, Celltrion has been working with Inhalon Biopharma, a bio-company from the U.S., to develop this inhalable form of Regkirona.
Inhalon had started non-clinical studies on rodents in January. The company has decided to proceed with phase one of the trial after confirming the safety and tolerability of repeated doses of Regkirona.
Celltrion expects its experimental COVID-19 drug to further increase the reach and accessibility of antibody therapeutics.
Celltrion pushes for accessibility in more countries
Regkirona is currently under review by the European Medicines Agency, while Celltrion is in talks with the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization of its COVID-19 treatment.
Saudi Arabia, the UAE, Jordan, Iraq, and Morocco are some of the other countries where the company filed for Regkirona’s approval.
In July, Regkirona received an emergency use authorization from the Indonesian government to use the drug in the country.
