EU approves Xevudy for COVID-19.- GSK + Vir Biotechnology

Sotrovimab is now approved in the European Union (EU) for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40kg) with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. The grant of the marketing authorization in the EU is a result of the positive opinion issued on December 16 by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The grant of the marketing authorization in the EU is based on data from the COMET-ICE Phase III trial, demonstrating that intravenous treatment with sotrovimab resulted in a 79% reduction (adjusted relative risk reduction) (p<0.001) in all-cause hospitalizations for more than 24 hours or death due to any cause by day 29 compared to placebo, meeting the primary endpoint of the trial. in absolute numbers, 30 (6%) of the 529 patients in the placebo arm progressed, compared to six (1%) of the 528 patients receiving sotrovimab. in clinical trials conducted to date, sotrovimab has been well-tolerated. the most common adverse reactions are hypersensitivity and infusion-related reactions, seen in approximately 2% and 1% of cases, respectively.></0.001)>