EMA starts rolling review of VIR 7831 in COVID-19.- GSK/Vir Biotechnology

GlaxoSmithKline and Vir Biotechnology announced that the European Medicines Agency has started a rolling review of data on VIR 7831 (sotrovimab), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19. The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. The rolling review will continue until enough evidence is available to support a formal marketing authorization application. The EMA will assess the medicine’s compliance with the usual standards for efficacy, safety and quality. While the overall review timeline cannot be forecast yet, the process should be quicker than a regular evaluation due to the time gained during the rolling review.The review of the data is being carried out by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The decision to start the rolling review is based on the 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 hospitalization. Results of the interim analysis, based on data from 583 randomized patients, demonstrated an 85% (p=0.002) reduction in hospitalizations over 24 hours or deaths in those receiving sotrovimab compared to placebo, the primary endpoint of the trial.