FDA Expands Emergency Use Authorization for Junshi/Lilly COVID-19 Neutralizing Antibody Cocktail for Post-Exposure Prophylaxis

Source: PharmaCube Info

Author: Yang Guang

On September 16, Eli Lilly announced that the U.S. FDA has expanded the Emergency Use Authorization (EUA) for the COVID-19 neutralizing antibody combination bamlanivimab (700 mg) and etesevimab (1,400 mg), developed in collaboration with Junshi Biosciences, to include individual post-exposure prophylaxis (PEP). Currently, this neutralizing antibody can be used for high-risk individuals aged 12 years and older (those who have not been fully vaccinated against COVID-19 or may not mount an adequate immune response to vaccination), as well as individuals exposed in institutional settings (e.g., nursing homes, prisons) where patients are infected with SARS-CoV-2.

This expanded authorization is based on data from the BLAZE-2 study. The study is a randomized, double-blind, placebo-controlled Phase III clinical trial designed to evaluate whether bamlanivimab administered alone or in combination with etesevimab can prevent SARS-CoV-2 infection and COVID-19, and to assess its safety and efficacy in nursing home residents and staff. The results showed that 4,200 mg of bamlanivimab reduced the risk of COVID-19 infection among nursing home residents by 80%, and among residents and staff in long-term care facilities by 57%.

Bamlanivimab (LY-CoV555), discovered by AbCellera and developed by Eli Lilly, is a potent, neutralizing IgG1 monoclonal antibody targeting the SARS-CoV-2 spike protein that prevents viral attachment and entry into human cells, thereby neutralizing the virus and potentially preventing and treating COVID-19.

Etesevimab (JS016 or LY-CoV016) is a recombinant fully human monoclonal neutralizing antibody that specifically binds with high affinity to the receptor-binding domain of the SARS-CoV-2 surface spike protein, effectively blocking the binding of the virus to the host cell surface receptor ACE2. Point mutations have been introduced into the native human IgG1 antibody to eliminate adverse effects such as tissue damage. This neutralizing antibody was co-developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Sciences (IMCAS). Subsequently, Eli Lilly and Company licensed etesevimab from Junshi Biosciences; Junshi Biosciences continues to lead development activities in the Greater China region, while Eli Lilly leads development activities in other regions worldwide.

On June 25, 2021, the U.S. Department of Health and Human Services (HHS) announced the suspension of distribution of the Junshi Biosciences/Eli Lilly COVID-19 neutralizing antibody cocktail therapy, as trial results showed that the neutralizing antibody exhibited no neutralizing activity against the Brazilian and South African variants. On August 27 of the same year, Eli Lilly announced that the FDA had reinstated the Emergency Use Authorization (EUA) for the COVID-19 neutralizing antibody bamlanivimab/etesevimab.

Note: The original text has been abridged.