GlaxoSmithKline and Vir Biotechnology’s COVID-19 Antibody Drug Granted FDA Emergency Use Authorization

Sotrovimab is an investigational single-dose monoclonal antibody that has been granted an EUA by the FDA for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. The FDA EUA aims to facilitate the availability and use of the investigational monoclonal antibody for the treatment of COVID-19 in the US while the pandemic remains a public health emergency. The FDA Fact Sheet for Healthcare Providers regarding the emergency use of sotrovimab reflects the recently updated definition of high risk for COVID-19 to include additional medical conditions and factors associated with increased risk for progression to severe disease. The EUA for sotrovimab also includes post-authorization commitments as specified in the Letter of Authorization.

The EUA was granted to sotrovimab based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial in high-risk adult outpatients, which was stopped early by an independent data monitoring committee in March 2021 due to evidence of profound clinical efficacy. Interim study results had demonstrated an 85% reduction in hospitalization for more than 24 hours or death in those receiving sotrovimab compared to placebo, the primary endpoint of the trial. The most common adverse events observed in the sotrovimab treatment group in COMET-ICE were rash (2%) and diarrhea (1%), all of which were Grade 1 (mild) or Grade 2 (moderate). No other treatment-emergent adverse events were reported at a higher rate with sotrovimab compared to placebo. The EUA includes a warning for hypersensitivity including anaphylaxis and infusion-related reactions.

Sotrovimab targets a conserved epitope of the spike protein that is less likely to mutate over time. The EUA submission also included data from published in vitro studies, which demonstrated that sotrovimab maintains activity against all known circulating variants of concern. GSK and Vir will continue to evaluate the ability of sotrovimab to maintain activity against new and emerging variants. The clinical impact of these in vitro variant data is not yet known. Data collection and analysis is still ongoing. An analysis of safety and efficacy data at day 29 for the full population from the COMET-ICE trial is expected as early as the first half of 2021. GSK and Vir plan to submit a Biologics License Application (BLA) to the FDA in the second half of 2021.

“Our distinctive scientific approach has led to a single monoclonal antibody that, based on an interim analysis, resulted in an 85% reduction in all-cause hospitalizations or death, and has demonstrated, in vitro, that it retains activity against all known variants of concern, including the emerging variant from India,” said George Scangos, Ph.D., chief executive officer of Vir. “I believe that sotrovimab is a critical new treatment option in the fight against the current pandemic and potentially for future coronavirus outbreaks, as well. At Vir, our aim is not only to deliver a clinically effective therapy for COVID-19, but also to provide effective therapy against SARS-CoV-2 variants and potential pandemics of tomorrow.”

“The fast pace of COVID-19 vaccinations in the U.S. is encouraging, yet, despite these aggressive efforts, there is still a need to help prevent infected patients from developing complications,” said Dr. Hal Barron, chief scientific officer and president R&D, GSK. “In just over a year since starting our collaboration and in less than 10 months since beginning clinical trials, we are delighted that, as of today, the benefits of this unique monoclonal antibody will now be available to patients in need.”

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GlaxoSmithKline plc
Vir Biotechnology, Inc.