South Korea gives nod to antibody treatment
Celltrion said this week that the Korean Ministry of Food and Drug Safety (MFDS) approved its monoclonal antibody treatment for the novel coronavirus, named regdanvimab (CT-P59).
Following the measure, the treatment commercially known as Regkirona will be extended to patients with mild or moderate symptoms.
After getting conditional approval early this year, the drug has been used for high-risk groups in South Korea aged older than 60.
“This marks the first time a monoclonal antibody treatment for COVID-19 has received a full approval to treat patients with COVID-19 from the Korean health authority,” a Celltrion official said.
“Recent clinical data have helped improve healthcare professionals’ and public health authorities’ understanding of the potential role of Regkirona in the treatment of patients with mild-to-moderate symptoms of COVID-19,” Celltrion senior official Kim Ho-ung said.
“Regkirona is the first of its kind for the treatment of COVID-19, so the efficacy and safety profile should be assessed thoroughly. Along with a continuous and positive feedback from expert scientists and clinicians, we are encouraged by the decision of regulatory agency to confirm this treatment is safe and effective.”
He added that Celltrion has been in diligent communication with other regulatory authorities worldwide.
As of September 2021, more than 14,857 people have been treated with Regkirona in hospitals located in South Korea.
The Incheon-based Celltrion is also working on an oral drug together with its U.S. partner Inhalon Biopharma. The latter recently gained the green light to conduct its trial in Australia.
Such companies as Pfizer and MSD are leading the development of oral antiviral drugs for COVID-19. They are currently carrying out the phase 3 trials for their drugs.