FDA restricts COVID-19 antibody therapies from Regeneron and Eli Lilly (updated)
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The FDA has restricted the use COVID-19 monoclonal antibody therapies developed by Regeneron (REGN
-3.0%) and Eli Lilly (LLY
-3.8%) citing their lack of efficacy against the Omicron variant.
The impacted therapies are Lilly's bamlanivimab and etesevimab (taken together) and Regeneron's REGEN-COV (casirivimab and imdevimab)

FDA Director of the Center for Drug Evaluation and Research Patrizia Cavazzoni late this afternoon said the two treatments would only be used "only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments."
In case the treatments become effective against a future variant, the FDA is likely to issue a revision to their emergency use authorizations rather than a withdrawal of regulatory clearance.
Accordingly, the Biden administration is set to pause the distribution of the treatment, noting that they should not be deployed in any of the states due to concerns over the efficacy against the new variant, which has fueled the latest surge of COVID-19 in the U.S.
However, a rival antibody therapy from GlaxoSmithKline (GSK
-2.8%) and Vir Biotechnology (VIR
-11.1%) was found to be effective against the variant, the companies said last month, citing lab-based studies.