On Jul. 28, 2021, GlaxoSmithKline and Vir Biotechnology announced they had signed a Joint Procurement Agreement with the European Commission to supply up to 220,000 doses of sotrovimab, an investigational single dose SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents (aged 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 Joint Procurement Agreement enabled participating European Union (EU) Member States to quickly purchase sotrovimab, following local emergency authorisation or authorisation at the EU level, to treat high-risk patients with COVID-19 who may benefit from early treatment with sotrovimab.

This action follows the positive scientific opinion issued by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), under Article 5(3) of Regulation 726/2004, which can be considered by the national authorities in EU Member States when taking evidence-based decisions on the early use of the medicine prior to marketing authorisation. Sotrovimab is included in the European Commission’s portfolio of promising candidate therapies as part of its COVID-19 Therapeutics Strategy. In addition, the documentation to support the forthcoming marketing authorisation application for sotrovimab is under rolling regulatory review with the EMA. In June, the companies announced confirmatory full results for the Phase 3 COMET-ICE trial, which resulted in a 79% reduction (adjusted relative risk reduction) (p<0.001) in 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.

Sotrovimab is an investigational SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. Sotrovimab, which incorporates Xencor’s Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.