EMA’s human medicines committee (CHMP) has completed its review on the use of the monoclonal antibody regdanvimab (also known as CT-P59) to treat patients with COVID-19. This review was undertaken to provide a harmonised scientific opinion at EU level to support national decision-making on the possible use of the antibody prior to marketing authorisation. The Agency concluded that regdanvimab can be used for the treatment of confirmed COVID-19 in adult patients who do not require supplemental oxygen therapy and who are at high risk of progressing to severe COVID-19.

The medicine is given by infusion (drip) into a vein and the proposed conditions of use are available.

EMA made its recommendations following a review of data from an ongoing study looking into the effects of regdanvimab in adult outpatients with COVID-19 symptoms described as mild to moderate who do not need supplemental oxygen. 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. In terms of safety, most side effects reported were mild or moderate. Reactions related to the infusion (including allergic reactions) cannot be excluded and healthcare professionals should monitor patients for these reactions.

Despite the uncertainties, the CHMP concluded that regdanvimab can be considered a treatment option for patients at high risk of progressing to severe COVID-19, based on a reasonable likelihood that the medicine may provide clinical benefit, and a low likelihood of harm.

EMA’s recommendations can now be used to support national advice on the possible use of this monoclonal antibody before a marketing authorisation is issued.

While the current evaluation has concluded, a rolling review of regdanvimab, which started on 24 February, is currently ongoing. Once finalised, the rolling review will be the basis for an EU marketing authorisation application for this medicine.

Posted on the EMA website on 26 March 2021