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September 20, 2021updated 02 Dec 2021 9:20am

Korean MFDS approves Celltrion’s regdanvimab for Covid-19 treatment 

In the Phase III trial, regdanvimab demonstrated a 72% reduction in the risk of Covid-19-linked hospitalisation or mortality.

The Korean Ministry of Food and Drug Safety (MFDS) has approved Celltrion Group’s regdanvimab (CT-P59) for extended use in adult and elderly people aged 50 years or above with Covid-19.

Celltrion noted that regdanvimab is the first monoclonal antibody therapy for Covid-19 to obtain full approval from the Korean MFDS.

The antibody treatment is intended for adults with moderate disease symptoms.

Elderly patients with mild symptoms and a minimum of one underlying medical condition such as obesity, cardiovascular disease, chronic lung disease, diabetes, etc., and those receiving immunosuppressive agents are eligible for the therapy.

Furthermore, the MFDS has lowered the administration duration for the approved dosage of single intravenous (IV) infusion of 40 mg/kg regdanvimab to 60 minutes from 90 minutes.

The Korean MFDS gave a conditional marketing authorization (CMA) in February for the emergency use of regdanvimab.

The CMA allowed the use of CT-P59 for treating adults aged 60 years or above with at least one underlying medical conditions and mild Covid-19 symptoms as well as adults with moderate symptoms.

Celltrion had enrolled more than 1,315 individuals in the international Phase III clinical trial assessing the efficacy and safety of regdanvimab in 13 countries including the US, Spain and Romania.

According to the results from the trial, regdanvimab substantially lowered the risk of Covid-19 associated hospitalisation or mortality by 72% for subjects who are at increased risk of disease progression and 70% for all subjects.

Celltrion Healthcare Medical and Marketing Division head Dr HoUng Kim said: “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.

“Along with a continuous and positive feedback from expert scientists and clinicians, we are encouraged by the decision of regulatory agency to confirm this treatment is safe and effective. Celltrion group remains in diligent communication with other regulatory authorities worldwide.”

Regdanvimab showed robust neutralising activity against the Delta variant of SARS-CoV-2 in pre-clinical studies.

In addition, all animals receiving the therapeutic dosage of the antibody had a 100% survival rate with virus eradication.

Last month, Health Canada granted priority review to Celltrion’s regdanvimab for the treatment of Covid-19.

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