On 18 November 2021, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) started evaluating the marketing authorisation application for the monoclonal antibody Xevudy (sotrovimab). The neutralising antibody inhibits SARS-CoV-2 infection of somatic cells. The applicant is GlaxoSmithKline Trading Services Limited, which developed the monoclonal antibody in collaboration with Vir Biotechnology.
Xevudy is intended for the treatment of adults and adolescents with COVID-19 who do not require supplemental oxygen therapy and who are at increased risk of severe COVID-19.
The CHMP will assess the benefits and risks of Xevudy in a shortened timeframe, allowing an opinion within two months. This short time interval is possible because the CHMP has already assessed data on the medicine as part of a rolling review. In this process results from laboratory and animal studies, data on the quality of the medicine, and data from a study on the safety and efficacy of sotrovimab in adults with mild COVID-19 symptoms who do not require supplemental oxygen and who are at increased risk of severe COVID-19 were assessed.
If the additional data now submitted with the marketing application are sufficient to reach a positive benefit-risk assessment, the CHMP will make a recommendation for approval to the European Commission, which will ultimately decide whether to grant marketing authorisation in the EU and EEA Member States.
Sotrovimab (also known as VIR-7831 and GSK4182136) is a monoclonal antibody that acts against COVID-19. A monoclonal antibody is protein that binds to a very specific structure (antigen). Sotrovimab is designed to attach to the spike protein of SARS-CoV-2. Binding to the spike protein reduces the ability of the virus to enter the body's cells. This is expected to reduce the severity of the disease and the need for hospitalisation in patients with COVID-19.
Updated: 19.11.2021
