POST Online Media Lite Edition


NEWLY REPORTED COVID-19 CASES (11.19.2021, 4:50pm CEST, WHO):   India 11,106    Brazil 11,977    United Kingdom 46,858    Russia 37,156    Turkey 22,234    France 19,840    Argentina 1,553    Germany 52,970    Spain 3,932    Columbia 2,257    Italy 10,645    Mexico 3,836    Ukraine 20,050    Poland 23,242    Philippines 1,297    Malaysia 6,380    Netherlands 23,680    Peru 1,370    Thailand 6,855    Czechia 13,374    Canada 2,448    Romania 3,076    Chile 2,611    Serbia 3,219    Sweden 1,210    Portugal 2,398    Vietnam 10,223    Kazakhstan 1,272    Austria 14,212    Hungary 11,289    Greece 7,276    Georgia 4,278    Bulgaria 2,785    Belarus 1,844    Slovakia 7,418    Azerbaijan 2,124    Croatia 7,270    Bolivia 1,119    Ireland 4,646    Lithuania 1,847    Denmark 4,013    South Korea 3,034    Slovenia 3,662    Latvia 1,221    Laos 1,401    China 31    New Zealand 200    Australia 1,302   

Eli Lilly is seeking an EUA for bamlanivimab and etesevimab together from FDA as COVID treatment

Christian Fernsby |
Eli Lilly and Company has requested the U.S. Food and Drug Administration (FDA) revoke the Emergency Use Authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg alone.

Article continues below

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.

What to read next

FDA seeks permanent injunctions against two stem cell clinics
Dramatic increase in e-cigarette use among youth in U.S.
Casirivimab and imdevimab reduced hospitalisation, death by 70% in non-hospitalised patients with COVID-19