Current approach on COVID-19 for Emergency Use Authorization in Europe: Sotrovimab

Abstract

Published on: October 2022Journal of Young Pharmacists, 2022; 14(4):372-376Review Article | doi:10.5530/jyp.2022.14.75 Authors:Sridevi Manni Gopalakrishnan, Shoba Elangovan, Sathyalakshmi Ramesh, Saba Maanvizhi*Department of Pharmaceutics, Sri Ramachandra Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu, INDIA. Abstract:COVID-19 plays a massive role in the health care sector. A coronavirus is a group of viruses that causes mild, moderate, and severe respiratory infections in humans. In recent times monoclonal antibodies have been used to treat and overcome the infection spread in mild to moderate infections of SARS-COV-2. It is a new neutralizing dual-action monoclonal antibody with an activity that plays a role against severe acute respiratory disorder coronavirus 2, known as SARS-CoV-2. Monoclonal antibodies are engineered molecules in the laboratory which acts as substitute antibody. Monoclonal antibodies can enhance and restore the attack of the immune system on pathogens. It is under development by GlaxoSmithKline, and Vir Biotechnology, Inc. Proteins developed by the laboratory have similar characteristics to natural antibodies produced from the human immune system. This sotrovimab is designed to avoid the entry of pathogens and viral attachment and neutralize the previously infected cells. It has been shown that there is a reduction level in hospitalization or death in age factor between 18-45 with mild-to-moderate COVID-19 by 79% who are at high risk of progressing to serious illness in COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial. Some of the adverse effects of the sotrovimab were rash and diarrhea (1%). Hypersensitivity reactions, including anaphylaxis, have been reported at at least rate. In this article, we have explained in detail the Sotrovimab overview, history, Clinical data, Special conditions, and Approval data of the European Union.Keywords: COMET-ICE trial, Coronavirus, Monoclonal antibodies, SARS-CoV-2, Sotrovimab.