US Pauses All Distribution of Eli Lilly’s COVID-19 Antibody
US paused the distribution of Eli Lilly’s COVID-19 antibody treatment after the CDC identified that the treatment may not be active against the Brazil or South African coronavirus variants.
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By - The Assistant Secretary for Preparedness and Response (ASPR) recently paused all distribution of Eli Lilly and Company’s COVID-19 antibody treatment.
CDC identified that the combined frequencies of the Brazil coronavirus variant, SARS-CoV-2 P.1/Gamma variant, and the South African coronavirus variant, B.1.351/Beta variant, now exceeds 11 percent and is trending upward throughout the US.
Overall data suggested that bamlanivimab and etesevimab administered together are not effective against either the P.1 or B.1.351 variants. These assays use “pseudotyped virus-like particles” that help determine the susceptibility of the live SARS-CoV-2 variant viruses.
“We are informing you that ASPR is immediately pausing all distribution of bamlanivimab and etesevimab together and etesevimab alone (to pair with existing supply of bamlanivimab at a facility for use under EUA 094) on a national basis until further notice,” ASPR said in the statement.
The organization stated that providers should review the antiviral resistance information in Section 15 of the authorized fact sheets for each monoclonal antibody therapy available under the emergency use authorization for details regarding specific variants and resistance.
FDA also recommended that healthcare providers nationwide use alternative authorized monoclonal antibody therapies, including Regeneron’s COVID-19 antibody cocktail, REGN-COV2 and GSK and Vir Biotechnology’s antibody therapy, sotrovimab, until further notice.
In November 2020, FDA issued an emergency use authorization to REGN-COV2 for adults and pediatric patients 12 years of age and older but did not authorize the treatment for hospitalized COVID-19 patients or those who require oxygen therapy.
Based on currently available vitro assay data, REGN-COV2 significantly reduced viral load and patient medical visits, including hospitalizations, emergency room visits, urgent care visits, and telemedicine visits in a Phase 2/3 randomized, placebo-controlled trial.
In May, FDA authorized sotrovimab for mild-to-moderate coronavirus in adults and pediatric patients 12 years of age and older who are at high risk for progression to severe COVID-19, including hospitalization or death.
The agency based its authorization on a Phase 1/2/3 randomized, placebo-controlled trial, which found that the treatment elicited an 85 percent reduction in hospitalization or death in patients compared to placebo.
ASPR and FDA will continue to work with the CDC to provide further updates and consider additional action as new information becomes readily available.
