Home » Covid, Gsk-Vir: Ema initiates monoclonal review for adults and adolescents

Covid, Gsk-Vir: Ema initiates monoclonal review for adults and adolescents

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Rome, April 15 (beraking latest news Health) – GlaxoSmithKline and Vir Biotechnology today announced that the European Medicines Agency (EMA) has initiated a review of Vir-7831, an investigational double-acting monoclonal antibody, for the treatment of adults and adolescents (aged 12 years or older and weighing 40 kg or more) with Covid-19 that do not require oxygen supplementation and are at high risk of progressing into a severe form of the disease. This is what is stated in a GSK note.

The review is conducted by EMA’s Committee for Medicinal Products for Human Use (CHMP) and will provide EU-wide recommendations for national authorities who can make evidence-based decisions on early use of the medicine, prior to any formal application. marketing authorization. The review will include data from an interim analysis of the efficacy and safety data from the phase 3 Comet-Ice study, which evaluated Vir-7831 as a monotherapy for early treatment of Covid -19 in adults at high risk of hospitalization.

The results of the interim analysis, based on data from 583 randomized patients, demonstrated an 85% reduction in hospitalization or death in those who received Vir-7831 compared to placebo, the primary endpoint of the study. As a result, the Independent Data Monitoring Committee recommended discontinuing the study for enrollment due to evidence of profound efficacy.

The review of the CHMP will also consider data on the quality and safety of the medicine. This week, the Australian Therapeutics Goods Administration (TGA), part of the Department of Health, granted Vir-7831 an interim determination. It is the first anti-Sars-Cov-2 monoclonal antibody to be awarded this designation which provides a formal and transparent mechanism to accelerate the registration of promising new drugs with preliminary clinical data. Vir-7831 is an experimental compound and has not obtained marketing authorization anywhere in the world. An emergency use authorization application for Vir-7831 has been submitted to the US Food and Drug Administration.

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Preclinical data “suggest that Vir-7831 targets a highly conserved epitope of the spike protein Sars-CoV-2, which may make resistance development more difficult. New in vitro data from pseudotypical virus assays published online at bioRxiv support this. hypotheses as they demonstrate that Vir-7831 maintains activity against current circulating variants of concern, including variants from the UK, South Africa and Brazil. Based on additional preclinical data published in bioRxiv, it appears that Vir-7831 also maintain activity against the California variant. Gsk plans to file a full marketing authorization application to EMA that will include data from the Comet-ice study, “explains a note.

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