FDA considers limiting authorization of certain monoclonal antibody treatments
CNN
Federal regulators are considering limiting the authorization of certain monoclonal antibody treatments that have not proved effective against the Omicron variant of the coronavirus, a source familiar with the decision-making told CNN.
The US Food and Drug Administration could decide in the coming days to take steps to curb the use of antibody treatments produced by Eli Lilly and Regeneron, the source said, pointing to the growing body of evidence that shows their monoclonal therapies don't effectively neutralize the virus' Omicron variant.
The National Institutes of Health had recently updated its guidelines to advise clinics against using these treatments on patients with mild to moderate Covid-19 due to their diminished effectiveness against the Omicron variant.
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