Celltrion Gains Regulatory Nod in Korea for Regdanvimab

Celltrion Group has been granted approval for regdanvimab (CT-P59) to be used as a treatment for COVID-19 by the Korean Ministry of Food and Drug Safety (MFDS). The regulatory authority’s decision was announced in a Sep. 18, 2021 press release.

Regdanvimab is a monoclonal antibody treatment that has been authorized for extended use in the treatment of COVID-19 in elderly patients (aged 50 years and over), or for those with at least one underlying medical condition with mild symptoms of COVID-19. Additionally, the approval covers treatment of adult patients with moderate symptoms of COVID-19. With this approval, regdanvimab becomes the first monoclonal antibody to be fully approved as a treatment for COVID-19.

“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,” said HoUng Kim, PhD, head of Medical and Marketing Division at Celltrion Healthcare, in the press release. “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. Celltrion group remains in diligent communication with other regulatory authorities worldwide.”