“This agreement with the European Commission represents a crucial step forward for the treatment of Covid-19 cases in participating EU member states, as it allows access to sotrovimab for high-risk patients who have contracted the virus“. George Katzourakis, Senior Vice President Europe of GlaxoSmithKline (GSK), comments on the joint procurement agreement signed by the British multinational and the American Vir Biotechnology with the European Commission to supply up to 220 thousand doses of sotrovimab, experimental monoclonal antibody to Sars-CoV-2 single dose for the treatment of adults and adolescents (aged 12 years or older and weighing at least 40 kg) with Covid-19, who do not require oxygen supplementation and are at risk of progressing to severe disease.
“As the Covid-19 landscape continues to evolve and we face new challenges, such as the Delta variant spreading around the world, there remains an urgent need for treatment options to help those who fall ill potentially avoid hospitalization or death “, emphasizes Katzourakis. Agree George Scangos, chief executive of Vir: “It remains very clear that further treatment options are needed to fully address the toll of this pandemic agreement recognizes that monoclonal antibody treatments for those who become infected are essential and we are pleased that European healthcare professionals and their patients now have access to sotrovimab. ”
“In particular – he highlights – the fact that sotrovimab was designed from the outset to maintain activity against the evolution of this virus, and has demonstrated in vitro its ability to maintain activity against circulating variants tested for concern. and interest, including Delta and Lambda, underlines their critical role in the fight against Covid-19 “.
The joint procurement agreement – explains a joint note from Gsk-Vir – allows participating European Union Member States to quickly purchase sotrovimab, subject to local emergency clearance or EU-wide clearance, for the treatment of high-risk Covid-19 patients who may benefit from early treatment with sotrovimab. This action follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency EMA, which can be considered by national authorities in EU member states when making evidence-based decisions on use. of the medicine before the marketing authorization (Aic).
Sotrovimab – the two companies recall – is included in the European Commission’s portfolio of promising candidate anti-Covid therapies. In addition, the documentation supporting Aic’s upcoming application for sotrovimab is under continuous regulatory review with the EMA. Sotrovimab obtained emergency use authorization from the American FDA in May. The drug has also been approved for emergency use in Bahrain, Kuwait, Qatar, Singapore and the United Arab Emirates.
In June GSK and Vir announced full confirmatory results for the Comet-Ice clinical phase 3 study, which led to a 79% reduction in hospitalizations for more than 24 hours or all-cause death from day 29 compared to placebo, reaching the primary endpoint of the trial. Furthermore, updated in vitro data published on the ‘bioRxiv’ pre-print platform demonstrates that sotrovimab maintains activity against currently circulating variants of the pandemic coronavirus, of concern and interest, including Alpha (B.1.1.7), Beta (B.1.351), Delta (B.1.617.2), Epsilon (B.1.427 / B.1.429), Gamma (P.1), Iota (B.1.526), Kappa (B.1.617.1) and Lambda (C.37) – the note lists – as well as for the new variants of Bristol (B.1.1.7 + E484K) and Cameroon (B.1.619), which encode for both mutations N440K and E484K which can lead to a reduced activity for other neutralizing monoclonal antibodies to Sars-CoV-2.