Eli Lilly is seeking an EUA for bamlanivimab and etesevimab together from FDA as COVID treatment
Lilly made this request due to the evolving variant landscape in the U.S. and the full availability of bamlanivimab and etesevimab together. This request is not due to any new safety concern.
This final step in Lilly's transition to only supply bamlanivimab and etesevimab for administration together in the U.S. for the treatment of COVID-19 – as planned with the FDA – follows the modification of contracts with the U.S. government to ensure adequate supply of etesevimab to be used together with bamlanivimab.
All sites in the U.S. now have access to obtain doses of etesevimab for administration with bamlanivimab—which together neutralize more of the emerging COVID-19 variants in the U.S. than bamlanivimab alone, including the rapidly growing B.1.427/B.1.429 California strain that currently accounts for 50 percent of the virus in California and over 10 percent across a number of additional states. In the U.S., bamlanivimab alone should no longer be administered. However, sites of care should not dispose of bamlanivimab supply; instead, they should order etesevimab to pair with it.
"Lilly moved quickly to make bamlanivimab alone available as a potentially lifesaving medicine at a time when Americans were hardest hit by COVID-19," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together."
Lilly's bamlanivimab was the first neutralizing monoclonal antibody to receive emergency use authorization from the FDA as a treatment for mild to moderate COVID-19 — providing a valuable treatment at a time when cases were at their highest in the U.S. More than 400,000 patients have been treated with bamlanivimab – more than any other neutralizing antibody – potentially preventing more than 20,000 hospitalizations and at least 10,000 deaths during the worst of the pandemic in the U.S.
Lilly developed bamlanivimab and etesevimab for administration together to meet the potential challenge of treatment-resistant variants likely to resist treatment with either monoclonal antibody used alone. Due to the rapidly evolving and geographically diverse nature of the SARS-CoV-2 virus, continued scientific innovation remains critical to develop additional treatments. Lilly remains committed to developing complementary neutralizing antibodies to address potential SARS-CoV-2 variants that may arise in the future.
Bamlanivimab and/or bamlanivimab administered with etesevimab are authorized under special pathways in 20 countries outside the U.S. spanning four continents. Both bamlanivimab alone and bamlanivimab and etesevimab together retain the neutralization effects against the vast majority of variants, including the UK (B.1.1.7.) variant, present in these other countries and remain an important treatment option. The degree of neutralization of the virus does not necessarily equate to improved clinical outcomes.
Lilly is not requesting the withdrawal of emergency authorization for bamlanivimab alone in any other jurisdiction at this time. However, its use together with etesevimab, where authorized and available, is preferred over bamlanivimab alone. Lilly, in collaboration with Amgen, expects to manufacture sufficient supply of bamlanivimab and etesevimab together to meet global supply needs. Going forward, Lilly will submit only bamlanivimab administered with etesevimab together for authorization globally with a full transition expected by June 2021. ■