CT-P59 marks the first monoclonal antibody to receive full approval from Korean MFDS to treat patients with Covid-19
Celltrion has received full approval from the Korean Ministry of Food and Drug Safety (MFDS) for its a monoclonal antibody treatment regdanvimab (CT-P59) to treat Covid-19.
The therapy was previously granted a Conditional Marketing Authorisation (CMA) from the Korean MFDS, for the emergency use in adult patients aged 60 years and above.
Current approval extends the use of regdanvimab in patients aged 50 years and above, with mild symptoms of Covid-19, and adult patients with moderate symptoms of Covid-19.
Also, it allows for use in older people with at least one underlying medical condition, be it obesity, cardiovascular disease, chronic lung disease, diabetes, chronic kidney disease, or chronic liver disease.
Celltrion said that regdanvimab is the first monoclonal antibody treatment to receive a full approval from the Korean MFDS to treat patients with Covid-19.
Celltrion Healthcare medical and marketing division head HoUng Kim said: “Recent clinical data have helped improve healthcare professionals’ and public health authorities’ understanding of the potential role of regdanvimab in the treatment of patients with mild-to-moderate symptoms of Covid-19.
“Regdanvimab 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.”
Regdanvimab was identified as a potential treatment for Covid-19 through screening of antibody candidates that showed potential in neutralising the SARS-CoV-2 virus.
In the Phase 1 and 2 clinical trials, the drug showed promising safety, tolerability, antiviral effect and efficacy profile in patients with mild- to- moderate symptoms of Covid-19.
Celltrion has completed enrolling more than 1,315 people in its global Phase 3 clinical trial, which evaluated the efficacy and safety of regdanvimab in 13 countries.
The Phase 3 study showed that the therapy significantly reduced the risk of Covid-19 related hospitalisation or death by 72% for high-risk patients and 70% for all patients.
Celltrion claimed that more than 14,857 people have been treated with regdanvimab in 107 hospitals in the Republic of Korea, as of September 2021.
Furthermore, the company has commenced the development of a neutralising antibody cocktail using CT-P59, to prevent new emerging variants of SARS-CoV-2.