Soon we could have an extra weapon to treat Covid: the European Medicines Agency (Ema) has expressed a positive opinion on sotrovimab, a monoclonal antibody developed by GSK and Vir Biotechnology. This is not yet a marketing authorization, but EU member states can decide to use the therapy on an experimental basis.
Good efficacy data
EMA’s Committee for Medicinal Products for Human Use (CHMP) evaluated the available data on the drug for early treatment of Covid in adults and adolescents (aged 12 years and over and weighing at least 40 kg) who do not require oxygen supplementation and who are at risk of progressing to severe forms. An interim analysis of the phase 3 study COMET-ICE (Covid-19 Monoclonal antibody Efficacy Trial – Intent to Care Early), in 583 randomized patients, showed an 85% reduction in hospitalization or death in those who received sotrovimab compared to placebo. The Independent Data Monitoring Committee recommended discontinuing the study, given the good efficacy and safety results.
Works against variants
According to several studies in vitrofurthermore, sotrovimab would be active against multiple variants of the virus: Brazilian (P.1), Californian (B.1.427 / B.1.429), South African (B. 1.351) and English (B.1.1.7). On the platform bioRxiv (preprint) further data has recently been published in vitro which demonstrate activity against the New York (B.1.526) and Indian (B.1.617) variants. Sotrovimab affects a Spike protein epitope that is unlikely to mutate over time. Epitopes are the parts of an antigen that the molecules of the immune system can attach to. The revision of the CHMP took place in parallel with the rolling review Ema (still in progress), at the end of which an application for marketing authorization will be presented. In the United States, GSK has asked the Food and Drug Administration (FDA) for the green light for the emergency use of sotrovimab: the ongoing evaluation.
The drug produced in Parma
Europe has been able to proceed quickly with this urgent assessment and today provides its Member States with the tool for an accelerated adoption of this new therapy which also responds to concerns about the continuous emergence of new variants of the virus, including the Indian one, ”he said. Fabio Landazabal, president and CEO of Gsk -. This therapy also speaks Italian, because it is produced in the GSK center of excellence in Parma for the whole world, as well as being subject to urgent review by the Italian Medicines Agency itself. I therefore hope that sotrovimab will soon be accessible to all Italian and European citizens, who can benefit from it as a complementary intervention to vaccination.
May 21, 2021 (change May 21, 2021 | 17:19)
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