KUALA LUMPUR, Sept 21 (Bernama) -- The Celltrion Group announced the Korean Ministry of Food and Drug Safety (MFDS) has approved regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19.
This is 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.
This marks the first time a monoclonal antibody treatment for COVID-19 has received full approval to treat patients with COVID-19 from the Korean MFDS, according to a statement.
“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 Head of Medical and Marketing Division at Celltrion Healthcare, Dr HoUng Kim, Ph.D.
The administration time for the recommended dosage of regdanvimab (CT-P59), a single intravenous (IV) 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 per cent for patients at high-risk of progressing to severe COVID-19 and 70 per cent 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 per cent 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.
More details at https://www.celltrionhealthcare.com.
-- BERNAMA
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