The opinion relates to the use of the investigational monoclonal antibody for the treatment of adults and adolescents ages 12 years and over and weighing at least 40 kg with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19.

The CHMP opinion can now be considered by the national authorities in European Union member states when making decisions on the early use of the medicine prior to marketing authorization.

Medicago, GSK tout positive COVID-19 vaccine results
Medicago and GlaxoSmithKline (GSK) announced positive interim phase II results for their adjuvanted COVID-19 vaccine candidate.

Sanofi, GSK COVID-19 vaccine to advance to phase III trials
Sanofi and GlaxoSmithKline's (GSK's) adjuvanted, recombinant COVID-19 vaccine candidate produced strong rates of neutralizing antibody responses in all...

GSK, Vir start EMA rolling review for anti-SARS-CoV-2 antibody
GlaxoSmithKline (GSK) and Vir Biotechnology have announced that the European Medicines Agency (EMA) has started a rolling review of data on sotrovimab,...

EMA to review GSK, Vir COVID-19 mAb
GlaxoSmithKline (GSK) and Vir Biotechnology announced that the European Medicines Agency (EMA) has started a review of VIR-7831 (GSK4182136), an investigational...

GSK, Vir file EUA submission for COVID-19 mAb treatment
GlaxoSmithKline (GSK) and Vir Biotechnology filed an emergency use authorization (EUA) application with the U.S. Food and Drug Administration for VIR-7831...