The European Medicines Agency (EMA) on Friday said its Committee for Medicinal Products for Human Use (CHMP) issued an opinion recommending GlaxoSmithKline and Vir Biotechnology's sotrovimab to treat COVID-19 in adults and adolescents aged 12 and older who do not require supplemental oxygen, but are still at risk of progressing to severe disease. The dual-action SARS-CoV-2 monoclonal antibody is also under review by the FDA to prevent at-risk patients with mild-to-moderate COVID-19 from getting worse.
"Monoclonal antibody treatments are a critical part of a comprehensive solution to COVID-19," remarked Christopher Corsico, senior vice president for development at GlaxoSmithKline, noting that such therapies "can slow the progression of disease in patients who are at high risk for developing severe complications."
The CHMP reached its opinion amid an ongoing EMA rolling review of data, including an interim analysis from the Phase III COMET-ICE trial, which evaluated sotrovimab monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation. Data from 583 patients showed an 85% reduction in hospitalisation or death among those given an infusion of the antibody therapy compared to placebo, achieving the study's primary endpoint. The positive results also prompted the independent data monitoring committee to recommend that the trial be stopped. Safety and efficacy analyses continue in the meantime, with data for the full COMET-ICE population anticipated as early as the first half of 2021.
The EU panel also looked at data from various laboratory studies suggesting sotrovimab maintains activity against multiple variants, including those first spotted in Brazil (P.1), California (B.1.427/B.1.429), South Africa (B.1.351) and the UK (B.1.1.7). In addition, the companies cited lab findings published by bioRxiv indicating that sotrovimab shows activity against variants from New York (B.1.526) and India (B.1.617) as well.
"Based on our most recent in vitro data, sotrovimab continues to combat COVID-19 as it evolves and has retained activity against all circulating variants of concern," commented Vir chief executive George Scangos. Sotrovimab, also known as VIR-7831, targets a conserved epitope of the SARS-CoV-2 spike protein, which the companies say is less likely to mutate over time.
Meanwhile, results from the Phase II BLAZE-4 trial demonstrated that the combination of sotrovimab and Eli Lilly's bamlanivimab cut viral loads more than placebo in low-risk adults with COVID-19. The US pulled its authorisation of bamlanivimab monotherapy last month because of concerns it may not be able to neutralise some variants circulating in the US. It is now only being supplied in the country as part of an antibody cocktail co-administered with etesevimab.
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