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The European Commission has entered into a supply agreement with GlaxoSmithKline and Vir Biotechnology for up to 220,000 doses of sotrovimab, an investigational mAb for treating COVID-19.
GlaxoSmithKline and Vir Biotechnology announced on July 28, 2021 that they signed an agreement with the European Commission (EC) to jointly supply up to 220,000 doses of sotrovimab, an investigational single-dose monoclonal antibody (mAb) in development for treating SARS-CoV-2 infection. The joint agreement will allow participating European Union (EU) member states quick purchase access to the mAb, following emergency authorization at the local level or at the EU level. Early access will allow for the treatment of high-risk patients with COVID-19.
The EC’s move follows a positive opinion granted by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP). Sotrovimab is included in the EC’s portfolio of promising COVID-19 candidate therapies. Documentation to support a marketing authorization application for the mAb is currently in an ongoing regulatory review with the EMA. GSK and Vir announced results in June 2021 from a Phase III clinical study, which met its primary endpoint and demonstrated a 79% reduction in hospitalizations.
Sotrovimab was granted Emergency Use Authorization in the United States in May 2021 for treating mild-to moderate COVID-19 in high-risk patients. GSK and Vir plan to submit a biologics license application to FDA in the second half of 2021. Other countries in which sotrovimab has been authorized for emergency use include Bahrain, Kuwait, Qatar, Singapore, and United Arab Emirates.
“This agreement with the [EC] represents a crucial step forward for treating cases of COVID-19 in participating EU Member States, as it enables access to sotrovimab for high-risk patients who have contracted the virus. As the COVID-19 landscape continues to evolve and we meet new challenges—such as the Delta variant spreading across the globe—there remains an urgent need for treatment options to help those who do get sick to potentially avoid hospitalization or death,” said George Katzourakis, senior vice-president, Europe, GSK, in a company press release.
“It remains abundantly clear that additional treatment options are needed to fully address the toll of this pandemic. This agreement recognizes that monoclonal antibody treatments for those who become infected are essential, and we are pleased that European healthcare providers and their patients now have access to sotrovimab. Notably, the fact that sotrovimab was designed from the beginning to maintain activity against the evolution of this virus and has demonstrated, in vitro, its ability to maintain activity against the tested circulating variants of concern and interest, including Delta and Lambda, underscore its critical role in the fight against COVID-19,” said George Scangos, CEO of Vir, in the press release.