Therapy Areas: Cardiovascular
Celltrion's Monoclonal Antibody Treatment for COVID-19, Regdanvimab (CT-P59) Becomes the First Authorized COVID-19 Treatment Approved from the Korean Ministry of Food and Drug Safety
20 September 2021 - - The Korean Ministry of Food and Drug Safety approved regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19 for the extended use in elderly patients aged 50 years and over, or with at least one underlying medical condition (the obese, cardiovascular disease, chronic lung disease, diabetes, chronic kidney disease, chronic liver disease, and patients with immunosuppressive agents) with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19, South Korea-based Celltrion Group said.

This marks the first time a monoclonal antibody treatment for COVID-19 has received a full approval to treat patients with COVID-19 from the Korean MFDS.

In February, the Korean MFDS granted a Conditional Marketing Authorisation for the emergency use of regdanvimab (CT-P59) and allowed the 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 administration time for the recommended dosage of regdanvimab (CT-P59), a single intravenous infusion of 40 mg/kg, has been reduced from 90 minutes to 60 minutes.

Celltrion has successfully enrolled more than 1,315 people in its global Phase III clinical trial, which evaluated the efficacy and safety of regdanvimab (CT-P59) in 13 countries including the US, Spain, and Romania.

Data showed regdanvimab (CT-P59) significantly reduced the risk of COVID-19 related hospitalisation or death by 72% for patients at high- risk of progressing to severe COVID-19 and 70% for all patients.

In addition, pre- clinical data for regdanvimab (CT-P59) demonstrated strong neutralising activity against the Delta variant (B.1.617.2, first identified in India) with results showing 100% survival rate with virus eradication from all animals treated with therapeutic dosage of CT-P59.

As of September 2021, more than 14,857 people have been treated with regdanvimab (CT-P59) in 107 hospitals in the Republic of Korea.

CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus. 

In vitro and in vivo pre- clinical studies showed that CT-P59 strongly binds to SARS-CoV-2 RBD and significantly neutralise the wild type and mutant variants of concern including the Alpha variant (B.1.1.7, first identified in the UK).

In in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global Phase I and II clinical trials of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild- to- moderate symptoms of COVID-19.

Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2.
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