GSK and Vir Biotechnology's Sotrovimab Receives FDA Emergency Use Authorization for High-Risk COVID-19 Patients

Compiled & Translated | newborn

On May 26, the U.S. FDA granted an Emergency Use Authorization (EUA) for the COVID-19 monoclonal antibody sotrovimab for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) who test positive for SARS-CoV-2 and are at high risk for progression to severe COVID-19, including hospitalization or death.

Sotrovimab is a neutralizing antibody jointly developed by GlaxoSmithKline (GSK) and Vir Biotechnology. This approval will provide another effective treatment option against the COVID-19 pandemic. Currently, the pandemic continues to spread across many countries worldwide, and new variants are continually emerging. The emergence of these variants may reduce the efficacy of certain therapeutics, such as specific neutralizing antibodies.

Data from the Phase 3 COMET-ICE trial demonstrate that sotrovimab reduces the risk of hospitalization or death by 85% compared with placebo in high-risk, newly diagnosed patients with COVID-19. The number of patients enrolled in this trial was comparable to or exceeded that of the pivotal clinical trials for Regeneron’s antibody cocktail therapy (casirivimab + imdevimab) and Eli Lilly’s antibody cocktail therapy (etesevimab + bamlanivimab). However, Lilly’s antibody cocktail therapy has been withdrawn in the U.S. states of Illinois and Massachusetts due to demonstrated ineffectiveness against a new variant.

In contrast, as a monoclonal antibody, sotrovimab appears capable of neutralizing every newly emerging variant. Originally isolated from a SARS survivor, sotrovimab was selected by Vir for development early in the pandemic due to its ability to broadly neutralize most viruses within the coronavirus family. Bob Nelsen, founder and venture capitalist at Vir, believes that unlike competing products, sotrovimab is likely to remain effective throughout the pandemic, even as the virus mutates.

George Scangos of Vir Biotechnology stated: “In in vitro studies, sotrovimab has been shown to retain activity against all known variants, including the new variant from India. I believe sotrovimab is a critical new therapeutic option for addressing the current COVID-19 pandemic and future coronavirus outbreaks.”

Despite this, the exact impact of Vir antibodies on the COVID-19 pandemic remains unclear. Even before vaccines were widely used, antibody therapies were not widely adopted in the United States, despite their effectiveness in preventing hospitalization and death.

George Scangos also discussed the possibility of distributing sotrovimab globally, but despite Vir's pledge at the end of 2020 to supply millions of doses in 2021, a GSK spokesperson declined to disclose how many doses are currently ready. They noted that sotrovimab will still take some time to be rolled out.

GSK and Vir announced that they will provide sotrovimab to eligible patients diagnosed with COVID-19 in the United States within the next few weeks. Currently, both companies are also actively collaborating with government agencies worldwide to provide sotrovimab to patients requiring treatment.

All COVID-19 neutralizing antibody therapies previously granted EUA have secured orders from the U.S. government, which manages their procurement and distribution. However, according to reports from the international biopharmaceutical media Endpoints News, sotrovimab has yet to receive any government orders and will be commercialized independently by Vir and GSK. Spokespersons from both companies stated that sotrovimab will be priced similarly to the per-dose rate charged to the government by Eli Lilly and Regeneron.

Source: FDA authorizes Vir-GSK antibody as variants threaten Eli Lilly mAb