The U.S. government has stopped its distribution of Eli Lilly's COVID-19 antibody bamlanivimab alone, saying that the increasing emergence of coronavirus variants has made the treatment ineffective, according to a March 25 Endpoints News report.
The FDA granted emergency use authorization to bamlanivimab Nov. 9 for use in patients with mild to moderate COVID-19. At the time, the agency said the drug was shown to reduce COVID-19-related hospitalizations and emergency room visits for high risk patients within 28 days after treatment.
On Feb. 9, the FDA granted emergency use authorization to Eli Lilly's COVID-19 antibody cocktail, a combination of antibodies bamlanivimab and etesevimab. The antibody cocktail, which is administered via a single intravenous infusion, is authorized to treat mild to moderate COVID-19 in patients ages 12 and older who are at high risk for severe COVID-19 or hospitalization.
The U.S. government is still distributing Eli Lilly's COVID-19 antibody cocktail, just not bamlanivimab alone. On Feb. 26, the U.S. purchased 100,000 doses of the antibody cocktail for $210 million.
“We recognize the U.S. 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 of SARS-CoV-2. The U.S. government has enabled direct ordering of bamlanivimab and etesevimab together as well as etesevimab alone, to pair with bamlanivimab that sites of care have on hand," Eli Lilly told Endpoints News.
Eli Lilly said March 10 the antibody cocktail reduced the risk of hospitalization and death by 87 percent during a phase 3 study involving 769 high-risk patients ages 12 and older with mild to moderate COVID-19.
The drugmaker is working with Amgen to manufacture up to 1 million doses of etesevimab for administration with bamlanivimab by midyear.
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