EMA issues positive scientific opinion on GSK and Vir Biotechnology’s sotrovimab for the early treatment of COVID-19.

The opinion relates to the use of sotrovimab for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19. The CHMP opinion under Article 5(3) can now be considered by the national authorities in EU member states when taking evidence-based decisions on the early use of the medicine prior to marketing authorisation. The CHMP reached its opinion following a review of data including an interim analysis of efficacy and safety data from the Phase III COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated sotrovimab as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation. Efficacy results of the interim analysis, based on data from 583 randomised patients, demonstrated an 85% (p=0.002) reduction in hospitalisation or death in those receiving sotrovimab compared to placebo, the primary endpoint of the trial. As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrolment due to evidence of profound efficacy. The CHMP also considered data on the medicine’s quality and safety.. The CHMP also reviewed data from several in vitro studies which demonstrated that sotrovimab maintains activity against multiple circulating variants of concern, including the variants from Brazil (P.1), California (B.1.427/B.1.429), South Africa (B.1.351) and the UK (B.1.1.7), based on in vitro data from live virus and pseudotyped virus assays. Additional in vitro data demonstrating activity against variants from New York (B.1.526) and India (B.1.617) were also recently published by bioRxiv. The clinical impact of these variants is not yet known. Sotrovimab targets a conserved epitope of the spike protein which is less likely to mutate over time. Data collection and analysis is still ongoing.. An Emergency Use Authorization (EUA) application for sotrovimab has been submitted to the FDA and it is also under review by other global regulators including Health Canada under the expedited Interim Order application pathway for COVID-19 drugs.