EMA Advises Limited Use of Celltrion COVID-19 Antibody Drug, Says Benefits Still Unclear

By Reuters Staff

March 29, 2021

(Reuters) - Europe's drug regulator said on Friday South Korean drugmaker Celltrion's COVID-19 treatment can be considered for patients at high risk of severe illness, but added that the monoclonal antibody's benefits were not entirely clear so far.

The treatment, regdanvimab, may lower hospitalisation rates, the European Medicines Agency (EMA) said, adding that its advice was based on the conclusion of an initial review.

The EMA's human medicines committee also concluded that regdanvimab can be used to treat confirmed COVID-19 in adult patients who do not need oxygen support.

"Results from the first part of the study indicate that regdanvimab may lower the rate of hospitalisation. However, the results were not robust enough to reach a firm conclusion on the medicine's benefits at this point in time," the EMA said (https://bit.ly/39fBchO).

The EMA review was undertaken to provide an opinion to individual European nations making assessments on the possible use of regdanvimab before a wider EU marketing authorisation is decided upon.

EMA's "rolling review" of the drug, aimed to speed up the process of approval by allowing researchers to submit findings in real time, is still ongoing.

Celltrion's drug, and similar ones from Lilly and Regeneron being reviewed by the EMA, are monoclonal antibodies, a class of treatments that studies so far suggest may be most effective early in the course of COVID-19.

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