Celltrion’s COVID-19 treatment candidate receives Korean MFDS Conditional Marketing Authorisation

Celltrion’s COVID-19 treatment candidate receives Korean MFDS Conditional Marketing Authorisation  

• Regdanvimab (CT-P59) receives conditional marketing authorisation from the Korean Ministry of Food and Drug Safety (MFDS); first anti-COVID-19 monoclonal antibody treatment to be approved in Korea 
• CT-P59 is authorised for the treatment of adult patients aged 60 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 
• Celltrion is under discussion with the European Medicines Agency (EMA) for Conditional Marketing Authorisation (CMA) and with the U.S. FDA for Emergency Use Authorisation (EUA) 

• The global Phase III clinical trial is on track and the trial is expected to enrol 1,172 patients with mild-to-moderate symptoms of COVID-19 

February 5 2021, INCHEON, KOREA – Celltrion Group today announced that the Korean Ministry of Food and Drug Safety (MFDS) granted a Conditional Marketing Authorisation (CMA) for the emergency use of Regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment candidate. The CMA allows for 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, high blood pressure) with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19. 

The CMA is based on Part 1 of the Phase II/III trial which showed; 

• Patients treated with CT-P59 reporting a significantly reduced risk of COVID-19 related hospitalization and oxygenation up to Day 28 
• Progression rates to severe COVID-19 were reduced by 54% for patients with mild-to-moderate symptoms and 68% for moderate patients aged 50 years and over 

• A significantly shortened time to clinical recovery in CT-P59 treated patients (40 mg/kg) ranging from 3.4 to 6.4 days quicker compared with placebo. 

“With the pandemic still raging in Korea, we believe today’s Conditional Marketing Authorisation of Regdanvimab marks an important milestone in the fight against COVID-19” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Patients with COVID-19 in Korea now have access to a therapy according to the authorised indications early in the course of their infection. We remain committed to closely working with the regulatory agencies worldwide including the U.S. FDA and the European Medicines Agency (EMA) to ensure that patients around the world have access to safe and effective treatment against COVID-19 as in the case of Korea.” 

A global Phase III clinical trial is currently recruiting and expected to enrol 1,172 patients with mild-to-moderate symptoms of COVID-19 in more than 10 global sites to evaluate efficacy and safety results of CT-P59. Celltrion is set to demonstrate clinical efficacy against COVID-19 in both UK and South African variants and the results to be expected in the coming days.