–In a webinar with the American Medical Association, FDA Acting Commissioner Janet Woodcock said that the US government Eli Lilly And Co’s (NYSE: LLY) Bamlanivimab will not be marketed in California, Arizona and Nevada amid prevalent COVID-19 virus variant.
A spokesman for Lilly told Endpoints News, “We recognize the US government’s decision to no longer allow direct ordering of bamlanivimab in California, Arizona and Nevada alone, due to concerns about the prevalence of the ‘California’ variant with the specific L452R substitution found in the B.1.429 / B.1.427 lines. It is important that preclinical data from our laboratories show that the combination of bamlanivimab and etesevimab retains its neutralizing effect especially against this variant. “
Woodcock indicated that the initial introduction of these monoclonal antibodies “was not the best” because they were in line with the distribution model of the antiviral remdesivir from Gilead Sciences, Inc. (NASDAQ: GILD) followed and “Hospitals were unable to issue monoclonals.”
John Farley, director of the FDA’s Infectious Disease Office, said the three approved monoclonal antibodies against the UK-derived variant will remain active. However, there are other, more worrying varieties ”and doctors should expect to see more information about these soon.
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Last month the US government agreed to purchase at least 100,000 doses of the combination therapy of bamlanivimab and etesevimab for $ 210 million, due for delivery later this month.
Last week, data from a Phase 3 study showed that the combination of bamlanivimab and etesevimab significantly reduced hospitalizations and deaths associated with COVID-19 in high-risk patients recently diagnosed with COVID-19.
LLY shares trade 0.07% lower at $ 186.60 in the pre-trading session on Thursday’s most recent review.
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