- Supply agreement is based on the European Commission (EC) Joint Procurement Agreement for sotrovimab.
- Sotrovimab received marketing authorisation from the EC for the early treatment of COVID-19 in December 2021.1
- Clinical trial data showed intravenous treatment with sotrovimab resulted in 79% reduction in all-cause hospitalisations for more than 24 hours or death due to any cause compared to placebo.2,3
GSK today announced that agreement has been reached with the Irish Government for the supply of COVID-19 treatment sotrovimab, developed in partnership with Vir Biotechnology.
The contract is enabled by the 2021 Joint Procurement Agreement (JPA) between GSK, Vir and the European Commission (EC) for the supply of up to 220,000 doses of sotrovimab to EU member states.
Following the December 2021 grant of marketing authorisation to sotrovimab for the early treatment of COVID-19 by the EC1, member states participating in the JPA, including Ireland, were able to proceed with ordering sotrovimab to support their pandemic response. Sotrovimab is now available in Ireland.
The grant of the marketing authorisation 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 hospitalisations 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. Interim data were published in The New England Journal of Medicine 2 on October 27, 2021 and final data were pre-published on November 8, 2021 on medRxiv.3
GSK and Vir are committed to the ongoing evaluation of sotrovimab as the COVID-19 landscape continues to evolve at different rates across the globe and new variants of concern and interest emerge. In vitro data, published in bioRxiv, demonstrate that sotrovimab retains activity against all tested variants of concern and interest of the SARS-CoV-2 virus as defined by the World Health Organization, including, but not limited to, Omicron (B.1.1.529), Delta (B.1.617.2), Delta Plus (AY.1 or AY.2) and Mu (B.1.621).4
Sotrovimab is a SARS-CoV-2 neutralising monoclonal antibody administered intravenously.
Important information about sotrovimab in the European Union
Sotrovimab is 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. It is recommended that sotrovimab is administered within five days of onset of COVID-19 symptoms.
Please review the Summary of Product Characteristics (SmPC) 5 for all safety information for sotrovimab. Healthcare professionals and patients are asked to report any suspected adverse reactions to www.hpra.ie.
About GSK in Ireland
GSK is a science-led global healthcare company. Our Dublin headquarters is home to our Pharmaceuticals and Consumer Healthcare businesses. Our pharmaceutical business is a leader in respiratory medicine, a major provider of vaccines to the HSE and an innovator in HIV medicine through ViiV Healthcare. The consumer business is a leader in pain relief and oral care in Ireland. For further information please visit www.gsk.ie.