EMA’s human medicines committee (CHMP) has completed its review on the use of the monoclonal antibody sotrovimab (also known as VIR-7831 and GSK4182136) 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 sotrovimab can be used to treat confirmed COVID-19 in adults and adolescents (aged 12 years and above and weighing at least 40 kg) who do not require supplemental oxygen therapy and who are at 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, including data on quality and from a study into the effects of sotrovimab in adult outpatients with mild COVID-19 symptoms who do not need supplemental oxygen. A planned interim analysis of this study indicated that sotrovimab reduced the risk of hospitalisation for more than 24 hours or death by 85% compared with placebo: hospitalisation for more than 24 hours or death occurred in 1% (3 out of 291) of patients who received sotrovimab and 7% (21 out of 292) of those who received placebo.

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.

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 sotrovimab, which started on 7 May, is 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 21 May 2021