The EUA was granted base on interim data from the Phase III COMET-ICE trial in high-risk adult outpatients.
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The U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to GlaxoSmithKline and Vir Biotechnology for sotrovimab, a single-dose monoclonal antibody, for mild-to-moderate COVID-19 in adults and children 12 years of age and older weighing at least 40 kilograms. The EUA was granted base on interim data from the Phase III COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial in high-risk adult outpatients.
The COMET-ICE trial was halted early by an independent data monitoring committee in March 2021 because of “profound clinical efficacy.” The data showed an 85% drop in hospitalization for more than 24 hours or death in patients receiving sotrovimab compared to placebo.
The most common side effects in the treatment group were rash (2%) and diarrhea (1%), all mild or moderate. No other treatment-emergent adverse events were observed. There is a warning in the EUA about hypersensitivity, including anaphylaxis and infusion-related reactions.
“With the authorization of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER). “It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of COVID-19 in the United States.”
Monoclonal antibodies are made in the laboratory and copy the immune system’s ability to fight off viruses and other pathogens. Sotrovimab specifically targets the SARS-CoV-2 virus’s spike protein, preventing the virus from attaching and entering human cells.
“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, 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 two companies are reviewing the complete data and expect to file for full approval in the second half of this year. Last week, the antibody therapy received a positive marketing recommendation from the European Medicines Agency (EMA)’s Committee for Human Medicinal Products (CHMP). It’s heading to the EMA for authorization as well.
There are two other authorized antibody cocktails by Regeneron and Eli Lilly. They are reportedly under-used because of low demand.
Adrienne E. Shapiro, an infectious disease specialist at Fred Hutchinson Cancer Research Center and investigator in the COMET-ICE trial, stated, “Monoclonal antibodies like sotrovimab are potentially one of our most effective tools for fighting COVID-19. While preventive measures, including vaccines, can reduce the total number of cases, sotrovimab is an important treatment option for those who become ill with COVID-19 and are at high risk — allowing them to avoid hospitalization or worse.”
