On 17 December 2021, the European Commission granted marketing authorisation for the monoclonal antibody Xevudy (sotrovimab) from GlaxoSmithKline Trading Services Limited for treating COVID-19. The authorisation followed the recommendation of the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) on 16 December 2021. Sotrovimab belongs to the group of SARS-CoV-2 neutralising antibodies.
As recommended by the Committee Xevudy is authorised for treating COVID-19 in adults and adolescents from 12 years of age and weighing at least 40 kilograms who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.
Xevudy is the third neutralising monoclonal antibody authorised in the EU for treating COVID-19. In reaching its conclusion, the CHMP evaluated data from a study involving 1,057 patients with COVID-19. The data showed that treatment with Xevudy significantly reduces hospitalisation and deaths in patients with at least one underlying condition that puts them at risk for severe COVID-19. Following treatment with Xevudy, only 1% of patients (6 out of 528) were hospitalised for longer than 24 hours within 29 days of treatment compared to 6% of patients on placebo (30 out of 529), two of whom died.
The majority of patients in the study were infected with the original SARS-CoV-2 virus. Some patients were infected with variants including Alpha and Epsilon. Findings from laboratory studies indicate that Xevudy is also expected to be effective against other variants (including Omicron).
The safety profile of Xevudy was favourable, with a small number of hypersensitivity (allergic) reactions and infusion-related reactions reported. The CHMP concluded that the medicine’s benefits are greater than its risks for the approved use.
The European Commission followed the CHMP's recommendation and granted marketing authorisation for Xevudy in the EU.
Sotrovimab (also known as VIR-7831 and GSK4182136) is a monoclonal antibody that is effective against COVID-19. The monoclonal antibody sotrovimab is a protein that attaches to the SARS-CoV-2 spike protein. This attachment to the spike protein reduces the virus’s ability to enter the cell. This is because the spike protein must attach to the receptor on the cell surface to be able to infect the cell. Treatment with a neutralising antibody is intended to reduce the severity of the illness and the number of hospitalisations of patients with COVID-19.
Updated: 17.12.2021
