The government stopped distributing the treatment on Tuesday.
Last week, the US Food and Drug Administration updated the guidance to say that therapy alone may not work as well against variants. Acting FDA Commissioner Janet Woodcock had said the US had stopped shipping bamlanivimab to Arizona, California and Nevada because of the variants, and the FDA asked the companies to evaluate their therapies against the variants.
Bamlanivimab can still be used with etesevimab, another monoclonal antibody treatment developed by Eli Lilly. In combination, Eli Lilly’s two treatments appear to work against variants of the coronavirus.
Operation Warp Speed invested heavily in the treatment throughout its development, and in December the US government spent $ 812.5 million to purchase an additional 650,000 doses of bamlanivimab. The government has shipped nearly 800,000 doses of bamlanivimab as of March 2. The updated guide says that if healthcare providers want to use their existing supply of bamlanivimab, they can.
“We acknowledge that the US government has made the decision to no longer allow the direct order of bamlanivimab only due to concerns about the prevalence of the California (B.1.427 / B.1.429) and New variants of SARS-CoV. York (B.1.526) -2, “Eli Lilly said in a statement Thursday; Last week, the US Centers for Disease Control and Prevention said the California strains are officially “variants of concern,” as they may be more transmissible and Covid-19 treatments may be less effective. against them.
“The US government has allowed the direct order of bamlanivimab and etesevimab together, as well as etesevimab alone, to be paired with bamlanivimab that care centers have on hand,” Lilly said in the statement. “We believe that sites with access to bamlanivimab and etesevimab for administration together should use that therapy over bamlanivimab alone. We remain committed to ensuring that patients who need access to neutralizing antibody therapy can obtain it.”
Clinical trials have shown that the combined treatment of etesevimab and bamlanivimab and an antibody therapy manufactured by Regeneron appear to significantly reduce hospitalization and deaths among Covid-19 patients who receive treatment early in the course of their disease. The Regeneron antibody cocktail also appears to work against variants circulating in the US.
In May, Dan Skovronsky, Lilly’s senior vice president and chief scientific officer, told CNN that even early on, he was researching various antibodies for additional versions of his Covid-19 treatments.
Eli Lilly opted for the single antibody approach in his first treatment because the single antibody seemed powerful enough. When a treatment requires more antibodies mixed in higher doses, “the harder it is to make,” Skovronsky said; at that time, there would not be enough capacity to produce all the necessary doses.
“The optimal scenario was one antibody in a relatively low dose, but whether it has to be two antibodies, higher doses, or even three antibodies mixed in higher doses, we will do whatever it takes to make the medicine effective for patients.” Skovronsky said. said in May.
Lilly is currently working with Amgen to expand the manufacture of etesevimab.