South Korea approves Celltrion’s COVID-19 treatment Regdanvimab for emergency use

pharmafile | February 8, 2021 | News story | Sales and Marketing COVID-19, celltrion 

The South Korean Ministry of Food and Drug Safety (MFDS) has granted a conditional marketing authorisation (CMA) for the emergency use of Celltrion’s Regdanvimab (CT-P59), a monoclonal antibody COVID-19 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 MFDS’ approval is based on part one of the Phase II/III trial, which showed patients treated with CT-P59 reporting a significantly reduced risk of COVID-19 related hospitalisation 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; and a significantly shortened time to clinical recovery in CT-P59 treated patients, ranging from 3.4 to 6.4 days quicker compared with placebo.

Dr HoUng Kim, Head of the Medical and Marketing Division at Celltrion Healthcare, said: “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.

“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 FDA and the 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 is 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, with results expected in the coming days. 

Darcy Jimenez

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