US to discontinue distribution of Eli Lilly antibody treatment

(CNN) – The US government, in partnership with Eli Lilly, said it will no longer distribute bamlanivimab, the monoclonal antibody therapy against covid-19, for use alone. The disruption is due to the “continued increase” of variants of the coronavirus in the country.

The government stopped distributing the treatment on Tuesday.

Last week, the U.S. Food and Drug Administration (FDA) updated its guidelines to clarify that therapy alone may not work as well against variants. Acting FDA Commissioner Janet Woodcock had said the US had stopped shipping the bamlanivimab treatment to Arizona, California, and Nevada because of the variants, and the FDA asked the companies to compare their therapies with the variants.

Bamlanivimab can still be used with etesevimab, another monoclonal antibody treatment developed by Eli Lilly. In combination, Eli Lilly’s two treatments seem to work against variants of the coronavirus.

Operation Warp Speed ​​invested heavily in the treatment during development, and in December, the US government spent $ 812.5 million to purchase an additional 650,000 doses of bamlanivimab. The government has distributed nearly 800,000 doses of bamlanivimab since March 2. The updated guide says that if healthcare providers want to use their existing supply of bamlanivimab, they can.

“We recognize that the US government made the decision to no longer allow direct order of bamlanivimab just because of concerns about the prevalence of California SARS-CoV-2 variants (B.1,427 / B.1,429) and New York (B. 1,526), ​​”Eli Lilly said in a statement on Thursday. Last week, the US Centers for Disease Control and Prevention (CDC) said the California tribes 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 the direct order of bamlanivimab and etesevimab together, as well as etesevimab alone, to be combined with the bamlanivimab available at health care centers,” Lilly said in the statement. “We believe that sites with access to bamlanivimab and etesevimab for joint application should use that therapy rather than bamlanivimab alone. We remain committed to ensuring that patients who need access to neutralizing antibody therapy can access it. ‘

Clinical studies have shown that the combination of etesevimab and bamlanivimab and an antibody therapy manufactured by Regeneron appears to significantly reduce the number of hospitalizations and deaths among COVID-19 patients treated early in their illness. 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 science officer, told CNN that, even from the start, they were researching different antibodies for additional versions of their COVID-19 treatments.

Eli Lilly chose the single antibody approach for his first treatment because the single antibody seemed potent enough. When a treatment requires more antibodies in higher doses, “the more difficult it is to produce,” Skovronsky said. At that point, there would not be enough capacity to produce all the necessary doses.

“The optimal scenario was one antibody at a relatively low dose, but if it is to be two antibodies, higher doses, or even three antibodies mixed in higher doses, we will do everything we can to make the drugs effective for patients,” said Skovronsky . said in May.

Eli Lilly is currently working with Amgen to expand production of etesevimab.