FDA requires Regeneron, Lilly to monitor variants as a condition of mAb EUAs
As part of an effort to shore up public confidence in the FDA’s emergency use authorization processes, the agency on Monday released additional scientific review documents on Eli Lilly’s and Regeneron’s monoclonal antibodies, which were authorized to treat mild to moderate Covid-19.
The newly released letters of authorization, which were updated in late February, show that the agency is increasingly concerned about the ability for certain variants, like B.1.351, the variant first identified in South Africa, to evade the antibody treatments.
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