EMA begins reviewing Celltrion Covid-19 treatment

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EMA begins reviewing Celltrion Covid-19 treatment

The European drug safety agency has begun reviewing of Korean biopharmaceutical giant Celltrion's Covid-19 antibody treatment.
 
The European Medicines Agency (EMA) said on Wednesday that it has started a "rolling review" of regdanvimab, also known as Regkirona, Korea's first homegrown Covid-19 treatment.
 
Celltrion, which won the local drug safety agency's conditional approval of the drug here, began supplying it to medical institutions in the country last week.

 
The EMA said the decision to start the rolling review is based on preliminary results from an ongoing study into the ability of the medicine to treat Covid-19.
 
The EMA said it has started evaluating the first batch of data, which includes animal studies and clinical trials, in addition to data on the quality of the medicine.
 
The process should be quicker than a regular evaluation due to the time gained during the rolling review, according to the EMA.
 
Regkirona is a monoclonal antibody with activity against Covid-19. A monoclonal antibody is a type of protein that has been designed to attach to a specific structure.
 
The treatment is administered to Covid-19 patients at higher risk, referring to people aged 60 and older, or with health conditions like heart disease, diabetes, high pressure or chronic diseases that affect the respiratory system.
 
Celltrion plans to conduct a global phase-three clinical trial, a pivotal part of the study, in more than 10 countries to obtain more comprehensive safety and efficacy results of the Covid-19 treatment.
 
Yonhap
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