Europe – EMA issues advice on use of regdanvimab for treating COVID-19

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…