Amid Variant Concern, US Government Stops Distribution Of Eli Lilly's Bamlanivimab In Three States

In a webinar with the American Medical Association, the FDA acting commissioner Janet Woodcock said that the U.S. government is not distributing Eli Lilly And Co’s LLY bamlanivimab in California, Arizona, and Nevada amid prevalent COVID-19 virus variant.

• A Lilly spokesperson, when spoke to Endpoints News, said, “We recognize the U.S. government has made the decision to no longer allow direct ordering of bamlanivimab alone in California, Arizona, and Nevada due to concerns about the prevalence of the ‘California’ variant, with the specific L452R substitution found in B.1.429/B.1.427 lineages. Importantly, preclinical data from our labs demonstrate that the combination of bamlanivimab and etesevimab maintains its neutralizing effect against this variant, specifically.”
• Woodcock suggested that the initial rollout of these monoclonal antibodies “wasn’t the greatest” because it followed Gilead Sciences, Inc’s GILD antiviral remdesivir distribution model, and “hospitals were in no position to give out monoclonals.”
• John Farley, director of the FDA’s office of infectious diseases, said that the three authorized monoclonal antibodies remain active against the variant originating in the U.K. Still, there are “other, more worrisome variants,” and physicians should expect to see more information on those soon.
• Last month, the U.S. government agreed to purchase a minimum of 100,000 doses of therapy combining bamlanivimab and etesevimab, for $210 million to be delivered this month.
• Last week, data from Phase 3 study showed that the combination of bamlanivimab and etesevimab significantly reduced COVID-19 related hospitalizations and deaths in high-risk patients recently diagnosed with COVID-19.
• Price Action: LLY shares are trading 0.07% lower at $186.60 in the premarket session on the last check Thursday.