U.S. Restricts Lilly Antibody Orders in 3 States on Mutant Worry

U.S. health officials have restricted orders of Eli Lilly and Co.’s single-antibody therapy in three states on concerns about efficacy against a new coronavirus variant identified in California earlier this year.

The limit on Lilly’s bamlanivimab affects California, Arizona and Nevada, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response said Thursday in a statement. Government officials are continuing to study whether to recommend the drug in areas where the variant, called CAL.20C, is prevalent.

Doctors and health officials are wary of the emergence of mutated forms of the coronavirus that have shown diminished responses to certain drugs and vaccines. After months of focus on strains identified in the U.K, South Africa and Brazil -- all of which have since appeared in the U.S. -- homegrown variants are now arousing fears.

The U.S. has billions of dollars in agreements for Covid-19 antibody therapies from Lilly and Regeneron Pharmaceuticals Inc. that it supplies to states. Two other antibody therapies -- an antibody cocktail from Regeneron and a similar combination from Lilly that includes bamlanivimab -- haven’t raised the same issues and can still be ordered by the three states, health officials said.

Lilly shares were little changed at $205.61 as of 3:14 p.m. in New York.

Lilly developed its combination therapy to address emerging coronavirus variants, according to a company statement. Bamlanivimab alone is able to neutralize viruses involved in 75% to 85% of U.S. Covid cases today, and the antibody combination does so in more than 99% of cases, according to Lilly. Tracking variants remains challenging, the company said.

“It’s important to note that bamlanivimab alone maintains its neutralizing effect against the vast majority of Covid-19 cases seen across the country today,” Lilly said in a statement.

Like Covid-19 vaccines, antibody drugs were developed rapidly with the aim of keeping patients out of hospitals and preventing the severely ill from overwhelming the nation’s health system. While their track record to date has been mixed, in part due to under-utilization, they are among only a small handful of new medical options available to clinicians to treat the disease itself.

The government action may represent another hurdle for antibody drugs, which are logistically challenging to administer because they must be given during the early, infectious phase of the illness. The government will allow ordering of etesivimab, the other drug in Lilly’s combination therapy, so it can be used along with bamlanivimab, Lilly said.

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