FDA Revises EUA for Lilly’s Antibody Cocktail to Prevent COVID-19
The FDA has expanded Emergency Use Authorization (EUA) for Eli Lilly’s combination antibody therapy, bamlanivimab and etesevimab, to include post-exposure prevention of COVID-19, in addition to treating people who are at high risk of progressing to severe disease.
The updated EUA was supported by a phase 3 study that showed bamlanivimab cut the risk of contracting symptomatic COVID-19 by up to 80 percent among nursing home residents and by up to 57 percent among both residents and staff.
Lilly has also made a deal with the U.S. government to supply 388,000 additional doses of etesevimab, to be used along with previously purchased bamlanivimab doses.
The government resumed distribution of the antibody combination earlier this month after pausing shipments over concerns about the treatment’s effectiveness against coronavirus variants.