The U.S. Department of Health and Human Services has paused the distribution of COVID-19 antibody therapies developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY), as well as one from another pharmaceutical company. The agency cites new data that shows the therapies are unlikely to be effective against the Omicron variant.
The Lilly therapies, bamlanivimab and etesevimab, received an Emergency Use Authorization in February to be used together to treat mild-to-moderate COVID-19 in patients 12 years of age and older who are at high risk for progressing to severe cases or hospitalization.
The EUA was expanded earlier this month to treat certain high-risk pediatric patients from birth to 12 years old.
However, the U.S. Food and Drug Administration says the distribution of the combination therapy, along with the REGEN-COV therapy from Regeneron Pharmaceuticals Inc. (Nasdaq: REGN), will remain paused “pending updated data from the CDC.”
The government did say sotrovimab, developed by United Kingdom-based GlaxoSmithKline (NYSE: GSK) and Vir Biotechnology (Nasdaq: VIR) in California, did show effectiveness against the Omicron variant and shipments of the drug have resumed after being paused last month.
A potential time frame for the pause on the Lilly and Regeneron drugs to be lifted was not given.