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European drug agency begins reviewing Celltrion's COVID-19 treatment

All News 09:42 February 25, 2021

By Kim Han-joo

SEOUL, Feb. 25 (Yonhap) -- The European drug safety agency has begun reviewing of South Korean biopharmaceutical giant Celltrion Inc.'s COVID-19 antibody treatment.

The European Medicines Agency (EMA) said on Wednesday (local time) that it has started a "rolling review" of regdanvimab, also known as Regkirona Inj., South Korea's first homegrown COVID-19 treatment.

This file photo, provided by South Korea's pharmaceutical giant Celltrion Inc. on Dec. 29, 2020, shows the company's anti-COVID-19 monoclonal antibody treatment. (PHOTO NOT FOR SALE) (Yonhap)

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 Inj. 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.


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