EU regulator says Celltrion’s COVID-19 antibody drug under real-time review

(Reuters) – Europe’s drug regulator said on Wednesday it was evaluating South Korean drugmaker Celltrion’s COVID-19 antibody treatment, the third such drug against the disease to go under real-time review in the region.

The European Medicines Agency (EMA) said its human medicines committee was assessing the first set of data it received from animal and human trials of the drug, regdanvimab, and will continue to study them as more data was submitted. (

Earlier this month, the EMA began evaluating antibody therapies developed by U.S. drugmakers Eli Lilly and Regeneron for use in some COVID-19 patients.

Celltrion’s drug and those from Lilly and Regeneron belong to a class of medicine called monoclonal antibody treatments, which mimic natural antibodies the body generates to fight infection.

Monoclonal antibody treatments can be synthesised in the laboratory and are already used to treat some types of cancer.

The EMA said it was “too early to draw any conclusions regarding the benefit-risk balance of the medicine”, as it has not yet evaluated all the data on regdanvimab.

FILE PHOTO: The logo of Celltrion is seen at the company’s headquarters in Incheon, South Korea, October 28, 2016. REUTERS/Kim Hong-Ji

Celltrion’s antibody treatment was conditionally approved in its home country earlier this month after early-stage data in November showed that it helped cut recovery time.

EMA’s “rolling reviews” are aimed to speed up the process of approving a successful vaccine or treatment by allowing researchers to submit findings in real time, even before the final trial data is ready.

Any endorsements by the EMA, however, have to be formally approved by the European Commission.

Reporting by Pushkala Aripaka in Bengaluru; Editing by Shinjini Ganguli


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