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The government stopped distributing the treatment on Tuesday.
Last week, the United States Food and Drug Administration updated its guidelines to say that therapy alone might not work as well against variants. Acting FDA Commissioner Janet Woodcock said the US has stopped shipping bamlanivimab to Arizona, California and Nevada due to the variants, and the FDA has asked companies to evaluate their therapies compared to variants.
Bamlanivimab can still be used with etesevimab, another monoclonal antibody treatment developed by Eli Lilly. In combination, the two Eli Lilly treatments appear to work against the coronavirus variants.
Operation Warp Speed has invested heavily in 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 sent nearly 800,000 doses of bamlanivimab as of March 2. The updated guidelines say that if healthcare providers want to use their existing offering of bamlanivimab, they can.
“We recognize that the US government has made the decision to no longer allow direct ordering of bamlanivimab alone due to concerns about the prevalence of the California (B.1.427 / B.1.429) and New York (B.1.526) variants. SARS-CoV -2, ”Eli Lilly said in a statement Thursday; Last week, the U.S. Centers for Disease Control and Prevention said the California strains are officially “variants of concern” because they may be more transmissible and Covid-19 treatments may be less effective against them.
“The US government has allowed direct ordering of bamlanivimab and etesevimab together as well as of etesevimab alone, to combine with bamlanivimab that health care sites have on hand,” Lilly said in the statement. “We believe that sites with access to bamlanivimab and etesevimab for co-administration should use this therapy rather than bamlanivimab alone. We remain committed to ensuring that patients who require neutralizing antibody therapy can. get.”
Clinical trials have shown that combined treatment with etesevimab and bamlanivimab and antibody therapy made by Regeneron appear to significantly reduce hospitalizations and deaths in patients with Covid-19 who are treated early in their illness. . Regeneron’s antibody cocktail also appears to work against variants circulating in the United States.
In May, Dan Skovronsky, senior vice president and chief scientific officer of Lilly, told CNN that even very early on, she was studying multiple antibodies for additional versions of her Covid-19 treatments.
Eli Lilly opted for the single antibody approach in his first treatment because the single antibody seemed potent enough. When a treatment requires more antibodies mixed at higher doses, “the harder it is to make it,” Skovronsky said; at the time, there would not have been enough capacity to produce all the necessary doses.
“The optimal scenario was an antibody at a relatively low dose, but if it is to be two antibodies, higher doses, or even three antibodies mixed at higher doses, we will do whatever it takes to. make a drug effective for patients, ”Skovronsky said in May.
Lilly is currently working with Amgen to scale up the manufacture of etesevimab.
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