Sotrovimab is a SARS-CoV-2 monoclonal antibody intended to treat Covid-19 in adults and adolescents, aged 12 years and above
GSK and Vir Biotechnology have signed a joint procurement agreement with the European Commission (EC) for up to 220,000 doses of sotrovimab, an investigational Covid-19 drug.
Sotrovimab is a SARS-CoV-2 monoclonal antibody intended to treat Covid-19 in adults and adolescents, aged 12 years and above, who are at risk of progressing to severe disease.
The move follows the positive opinion by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), for use of sotrovimab.
Also, the drug was granted the US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) in May this year to treat mild to moderate Covid-19 in high-risk patients.
GSK and Vir intend to file a Biologics License Application (BLA) with the FDA later this year.
GSK Europe senior vice-president George Katzourakis said: “This agreement with the European Commission 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 hospitalisation or death.”
The joint procurement agreement provides the European Union (EU) member states with rapid access to sotrovimab, following regulatory authorisation.
The EC has included sotrovimab in its portfolio of promising candidate therapies as part of its Covid-19 therapeutics strategy.
Also, sotrovimab is currently under rolling regulatory review with the EMA to support the marketing authorisation application in future.
In June, the companies announced confirmatory full results for the Phase 3 COMET-ICE trial, which reached the primary endpoint.
The study showed that treatment using sotrovimab reduced 79% of hospitalisations or death due to any cause, for more than 24 hours compared to placebo.
Vir CEO George Scangos said: “It remains abundantly clear that additional treatment options are needed to fully address the toll of this pandemic.
“This agreement recognises 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.”