EU Drug Regulator Begins Rolling Review Of South Korean COVID-19 Treatment

The European Medicines Agency began on Wednesday a rolling review of data sent by South Korean drugmaker Celltrion on its experimental antibody treatment for the coronavirus

BRUSSELS (UrduPoint News / Sputnik - 24th February, 2021) The European Medicines Agency began on Wednesday a rolling review of data sent by South Korean drugmaker Celltrion on its experimental antibody treatment for the coronavirus.

"The decision to start the rolling review is based on preliminary results from an ongoing study looking at the ability of the medicine to treat COVID-19," an EMA statement read.

EMA's human medicines committee will be evaluating animal studies and clinical trials of the promising antibody medicine, called Regdanvimab, as they become available, in order to speed up the authorization process.

There is no timeline for the review. The expert committee has not yet evaluated the first full batch of data and cannot draw any conclusions on possible risks or benefits of the drug, the agency said.