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For the management of coronavirus disease, FDA has authorized bebtelovimab that retains significant activity against the highly transmissible omicron variant.
For the treatment of mild to moderate coronavirus disease, an emergency use authorization (EUA) for bebtelovimab was granted by Food and Drug Administration (FDA) on 11 February 2022 after bebtelovimab showed neutralization against all the circulating SARS-CoV-2 variants of concern, including omicron and its subvariant BA.2.
Bebtelovimab's EUA (supported by non-clinical and clinical data) is for the management of coronavirus disease in adults and pediatrics (age twelve years and above, weighing at least 40 kilograms/about 88 pounds) having a positive SARS-CoV-2 test, and who are at elevated risk for advancement to severe coronavirus disease, including hospitalization or mortality, and for whom alternative SARS-CoV-2 therapeutic options approved or authorized by United States FDA are inaccessible or clinically inappropriate.
The monoclonal antibody (mAB) bebtelovimab is not authorized for people who are hospitalized or need oxygen treatment due to coronavirus disease. Bebtelovimab therapy has not been investigated in individuals hospitalized due to coronavirus disease. Bebtelovimab might be linked with poor clinical outcomes when given to hospitalized people suffering from SARS-CoV-2 needing mechanical ventilation or high flow oxygen.
Bebtelovimab's clinical data are from a randomized, single-dose, phase II study assessing the effectiveness of bebtelovimab alone and bebtelovimab + other mAbs to treat coronavirus disease. This mAB works by binding to spike protein of virus that elicits SARS-CoV-2, similar to other mAbs that have been approved to treat high-risk individuals having mild to moderate coronavirus disease and have demonstrated a benefit in decreasing the risk of hospital admission or mortality.
Laboratory testing revealed that bebtelovimab retains activity against both BA.2 omicron subvariant and omicron variants. Overall, 380 low-risk people (i.e., people without known risk factors for advancement to severe coronavirus illness) were recruited in the placebo-controlled portion of the study.
In this part of the study, the volunteers were randomly allocated to get a single infusion of placebo, bebtelovimab alone, or bebtelovimab with other mAbs. Bebtelovimab therapy led to a decrease in time to sustained symptom resolution in comparison with placebo. Following therapy, a decrease in viral load relative to placebo was also noted on the 5th day.
In another portion of the study including mostly high-risk people (i.e. people with risk factors for advancement to severe SARS-CoV-2 illness), 150 people were randomly allocated to get bebtelovimab alone or bebtelovimab with other mAbs. In an open-label therapeutic arm, an extra 176 high-risk people were given bebtelovimab with other mAbs.
The rates of SARS-CoV-2 linked hospital admission and mortality through Day 29 reported in people who were given bebtelovimab alone or with other mAbs were usually lower when compared to the placebo rate noted in previous trials of other mAbs in high risk people. The clinical data were same for bebtelovimab alone in comparison with combination of bebtelovimab with other mAbs. Rash, nausea, itching, vomiting, and infusion-linked reactions were the possible adverse effects of bebtelovimab therapy.
Bebtelovimab is not an alternative option for vaccination in people for whom SARS-CoV-2 vaccination and a booster dose are suggested. The FDA has authorized two vaccines and approved others for preventing coronavirus disease and the severe clinical outcomes linked with COVID-19, including mortality and hospitalization. As novel variants of coronavirus continue to emerge, bebtelovimab's authorization is a crucial step to fulfill the needs of patients and medical care providers who continue to battle this pandemic.
US-FDA
Coronavirus (COVID-19) Update: FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant
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