The FDA has rescinded the emergency use authorization for Eli Lilly's monoclonal antibody drug, bamlanivimab, for use on its own to treat mild to moderate COVID-19 cases.
The drug is still authorized to be used in combination with etesevimab, another monoclonal antibody drug. A clinical trial showed the combination of antibody drugs reduced the risk of hospitalization and death by 87 percent, Eli Lilly said in March.
The FDA said it's rescinding the emergency authorization because bamlanivimab on its own isn't effective against COVID-19 virus variants, which are becoming more common. As of mid-March, about 20 percent of virus variants in the U.S. were expected to be resistant to the drug, compared to 5 percent in January, the agency said.
Since the number of virus variants resistant to the drug is growing, the FDA said the benefits of treating COVID-19 with bamlanivimab alone "no longer outweigh the known and potential risks for its authorized use."
Bamlanivimab was the first monoclonal antibody drug to be approved to treat mild to moderate COVID-19 in November. HHS said in March it had stopped shipping bamlanivimab on its own and was only shipping it in combination with etesevimab. On Feb. 26, the U.S. purchased 100,000 doses of the antibody cocktail for $210 million.
Read the FDA's full news release here.
More articles on pharmacy:
Merck halts development of one of its COVID-19 drugs
Scant evidence links J&J vaccine, blood clots, drugmaker's scientists say
J&J vaccine pause continues: Why Fauci thinks it could be a good thing