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To treat COVID-19, concomitant
administration of etesevimab and bamlanivimab has received emergency use
authorization (EUA) by Food and Drug Administration (FDA).
On 9th February 2021, the United States-FDA issued a EUA for etesevimab and bamlanivimab given together for managing mild-to-moderate coronavirus infection in adults and pediatrics (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and those at elevated risk for advancing to serious coronavirus infection.
Etesevimab and bamlanivimab are monoclonal antibodies that are particularly directed against the spike protein of the virus. These antibodies are developed to impede the attachment and entrance of the deadly virus into host human cells. Both these antibodies link to distinct but overlapping sites on the virus's spike protein.
The authorized usage incorporates therapy for individuals 65 years of age or older or those having specific chronic medical conditions. In the clinical trial of individuals suffering from COVID-19 at elevated risk for disease advancement, a single intravenous infusion of etesevimab and bamlanivimab administered together considerably declined coronavirus-associated hospitalization and mortality during 29 days of follow-up in comparison with placebo. The efficacy and safety of this investigational treatment for usage in mitigating coronavirus infection continue to be assessed.
For coronavirus-infected individuals who are hospitalized or require oxygen therapy, etesevimab and bamlanivimab are not authorized. In individuals hospitalized due to coronavirus infection, therapy with etesevimab and bamlanivimab has not been investigated. Monoclonal antibodies like bamlanivimab and etesevimab may be linked with unsatisfactory clinical outcomes when given to hospitalized individuals suffering from coronavirus requiring mechanical ventilation or high flow oxygen.
The data favoring this EUA are based on a randomized, double-blind, placebo-controlled study. The study cohort incorporated 1,035 non-hospitalized adults suffering from mild to moderate coronavirus symptoms who were at elevated risk for advancing to severe coronavirus infection. Participants were randomized to either a single infusion of 2,800 milligrams etesevimab and 2,800 milligrams bamlanivimab together (n=518) or placebo (n=517). The coronavirus-associated hospitalizations or mortality by any cause during 29 days of follow-up was the major outcome parameter ascertained. Hospitalization or mortality occurred in 7% (n=36) of participants treated with placebo in comparison with 2% (n=11) of participants receiving concomitant administration of etesevimab and bamlanivimab, a 70% decline. In the placebo recipients, 10 deaths (2%) deaths were found to occur. Compared to the placebo arm, the all-cause mortality was considerably reduced in the etesevimab and bamlanivimab arm.
The approved dose of 700 mg bamlanivimab and 1400 mg etesevimab to be administered together is based on the published preclinical, clinical, and virologic data. This supports that the authorized dose will exhibit comparable clinical effects with the concomitant dosing of both 2,800 mg etesevimab as well as bamlanivimab.
The FDA published a EUA on 9 November 2020 for a single infusion of 700 mg bamlanivimab to treat mild-to-moderate coronavirus infection in adult patients and certain pediatrics. While concomitant administration of etesevimab and bamlanivimab led to a reduced risk of resistant viruses developing during therapy vs. bamlanivimab given alone, both the therapies are anticipated to benefit individuals at elevated risk of disease advancement. Presently, both 700 milligrams bamlanivimab alone and 700 milligrams bamlanivimab and 1,400 milligrams etesevimab given concomitantly will be available under the EUA.
Severe and unanticipated side effects including anaphylaxis, hypersensitivity, and infusion-associated reactions have been witnessed with bamlanivimab with and without coadministration of etesevimab. Furthermore, the clinical deterioration after bamlanivimab therapy has been reported. But, it is not familiar whether these events were associated with bamlanivimab usage or were due to the advancement of coronavirus infection. Pruritus, nausea, rash, and dizziness were the possible adverse effects of concomitant administration of etesevimab and bamlanivimab.
FDA
Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
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