Green light from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency EMA to the monoclonal antibody sotrovimab of GlaxoSmithKline (Gsk) and Vir Biotechnology for the early treatment of Covid-19. The CHMP has expressed a positive opinion that the EU member states – underline the British company and its American partner – will now be able to use to make national decisions on the early use of the product before the marketing authorization (Aic ) of the Ema. The expert opinion refers to the use of sotrovimab for the treatment of adults and adolescents (aged 12 years and above and with a body weight of at least 40 kg) with Covid-19, who do not require supplementation of oxygen and are risk of progressing to a severe form of the disease. The CHMP – Gsk and Vir report in a note – reached its opinion after a review of the data, including an interim analysis of the efficacy and safety results of the phase 3 Comet-Ice study, which evaluated sotrovimab as monotherapy for the early treatment of Covid-19 in adults at high risk of hospitalization. Data from 583 randomized patients demonstrated an 85% reduction in hospitalization or death in those receiving sotrovimab compared to placebo, the primary endpoint of the study. A result according to which the Independent Data Monitoring Committee recommended discontinuing enrollment in the trial, due to evidence of profound efficacy. ‘Positive data also against variants, including the Indian one’ The Ema Committee – the note continues – also considered the data on the quality and safety of the drug. It also reviewed the results of several in vitro studies that demonstrated that sotrovimab maintains activity against multiple problematic circulating variants of Sars-CoV-2, including those from Brazil (P.1), California (B.1.427 / B. 1.429), South Africa (B.1.351) and the United Kingdom (B.1.1.7), based on in vitro data from live virus and pseudotyped virus assays. In addition, the ‘bioRxiv’ pre-print platform recently published additional in vitro results demonstrating activity against the New York (B.1.526) and India (B.1.617) variants. In fact, Sotrovimab targets a conserved epitope of the pandemic coronavirus Spike protein, which is less likely to mutate over time. The collection and analysis of the data is still in progress.The revision of the CHMP – the note continues – took place in parallel with the cyclical review of the EMA, ‘rolling review’ which is currently underway and will continue until they are available. sufficient evidence to support a formal MA application. An Emergency Use Authorization (Eua) application for sotrovimab has been filed with the United States Food and Drug Administration (Fda) and is also under review by other global regulatory bodies, including Health Canada, in within the accelerated path of ‘Interim Order application’ for Covid-19 drugs. Landazabal (Gsk Italy), ‘therapy produced in Parma for the whole world’ “While the Covid-19 pandemic continues and the virus generates new variants that cause concern , including those recently emerged in India, the need for therapies that can slow disease progression in patients at high risk of developing serious complications remains a top priority – says Christopher Corsico, Senior Vice President, Development, Gsk – Monoclonal antibody treatments are a key part of a comprehensive solution to Covid-19, especially since less than 40% of adults in EU member states have received at least one dose of a vaccine to date. We are encouraged by this positive scientific opinion from EMA, as it is hoped that it will bring us closer to making sotrovimab available to patients across Europe. “” Today’s opinion is excellent news for patients across Europe, as States EU members are now more easily able to proceed with their own temporary authorizations for sotrovimab – says George Scangos, Vir’s chief executive – Based on our most recent in vitro data, sotrovimab continues to fight Covid-19 as it evolves and it has maintained activity against all circulating variants of concern. We look forward to continuing to work with regulatory authorities around the world to make sotrovimab available to more patients in need and help end the pandemic. “” Europe has been able to move fast in this urgency assessment and today provides to its Member States the tool for an accelerated adoption of this new anti Covid-19 therapy which also responds to concerns about the continuous emergence of new variants of the virus, including the Indian one “, comments Fabio Landazabal, president and CEO of Gsk SpA. “This therapy also speaks Italian – he remembers – 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 drug agency Aifa 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 “.