Tuesday, 29 November 2022

Korea approves first anti-COVID-19 monoclonal antibody treatment

08 February 2021 | News

CT-P59 is approved for the treatment of patients aged 60 years and over, or with at least one underlying medical condition, with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID- 19

Photo Credit: Freepik

Photo Credit: Freepik

Celltrion Group has announced that the Ministry of Food and Drug Safety (MFDS) of South Korea has granted conditional marketing authorization (MA) for the emergency use of regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment candidate. Conditional Marketing Authorization allows emergency use of CT-P59 in adult patients aged 60 years and over, or with at least one underlying medical condition (cardiovascular, chronic respiratory disease, diabetes, elevated blood pressure) mild symptoms of COVID-19, and in adult patients with moderate symptoms of COVID-19.

The conditional MA is based on Part 1 of the Phase II / III trial and showed the following results:

  • Patients treated with CT-P59 showed a significant reduction in the risk of hospitalization and oxygenation related to COVID-19 through day 28
  • Rates of progression to severe COVID-19 reduced by 54% for patients with mild to moderate symptoms and 68% for patients with moderate symptoms aged 50 and over
  • A significant reduction (between 3.4 and 6.4 days) in the duration of clinical recovery in patients treated with CT-P59 (40 mg / kg) compared to placebo.

“ With the pandemic still raging in Korea, we believe this conditional marketing authorization for regdanvimab represents an important step in the fight against COVID-19,” says Dr HoUng Kim, Ph.D., head of the medical and marketing division of Celltrion Healthcare. 

A global Phase III clinical trial is being recruited (1,172 patients planned) for mild to moderate symptoms of COVID-19 at more than 10 sites worldwide to assess the efficacy and safety results of CT -P59. Celltrion is in the process of demonstrating clinical efficacy against COVID-19 for the British and South African variants. The results are expected in the coming days.

Sign up for the editor pick and get articles like this delivered right to your inbox.

Editors Pick
+Country Code-Phone Number(xxx-xxxxxxx)


× Your session has been expired. Please click here to Sign-in or Sign-up
   New User? Create Account