EMA recommends GSK’s Xevudy for the treatment of COVID-19

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended that GlaxoSmithKline (GSK)’s monoclonal antibody Xevudy (sotrovimab) for the treatment of COVID-19.

The committee recommended that Xevudy be authorised for the treatment of 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 monoclonal antibody recommended in the EU for treating COVID-19 and follows the approval of Regkirona and Ronapreve in November. It targets the Spike (S) protein, a extracellular protein on the surface of the SARS-CoV-2 virus (which causes COVID-19), that is required for the virus to bind to human cells and infect them.

The recommendation was based on the evaluation of data from a study involving 1,057 patients with COVID-19. The research found treatment with Xevudy significantly reduces hospitalisation and deaths in patients with at least one underlying condition putting them at risk of severe COVID-19. Following treatment with Xevudy, one percent of patients (six out 528) were hospitalised for longer than 24 hours within 29 days of treatment compared with six percent 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; however, some were infected with variants including Alpha and Epsilon. Based on laboratory studies, Xevudy is also expected to be active against other variants, including Omicron.

The safety profile of Xevudy was favourable, with a small number of hypersensitivity (allergic) reactions and infusion-related reactions. As a result, the CHMP concluded that the medicine’s benefits are greater than its risks for the approved use.

The CHMP will now send its recommendations to the European Commission for a rapid decision applicable in all EU Member States.

The medicine has already been made available to some patients in the EU under emergency/early use programmes, on the basis of advice given by the CHMP while the formal marketing authorisation application was evaluated.

Xevudy was developed by GSK in collaboration with Vir Biotechnology.