U.S. Halts Shipments of Lilly Antibody Combo, Citing Resistance in Patients

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U.S. health officials paused distribution of Eli Lilly & Co.’s combination antibody therapy because of fears it won’t combat two increasingly common coronavirus variants.

Resistance to the antibody treatment was detected among the gamma and beta variants of the virus, according to a statement from the Department of Health and Human Services. Medical providers should use other antibody treatments from Regeneron Pharmaceuticals Inc. and GlaxoSmithKline Plc instead, they said.

Lilly had developed the treatment, which consists of two antibodies, bamlanivimab and etesevimab, to safeguard against variants. The government halt highlights growing concerns about how mutated forms of the virus could undermine medical tools. The gamma and beta variants together make up more than 11% of sequenced U.S. cases, the statement said.

The combination was cleared by the Food and Drug Administration for U.S. use in February, and sales of it along with bamlanivimab alone brought in about $810 million in revenue for Lilly in the first quarter. The shares fell 0.7% at 3:39 p.m. in New York.

Variants’ prevalence can vary by area and change quickly, Lilly said in a statement, and it continues to monitor how its antibodies work against “a wide array of existing and emerging mutations and variants.”

“As variants continue to evolve and their patterns of transmission and prevalence shift, we will continue our work with governments and regulators worldwide to ensure our antibodies are available to appropriate patients,” the company said.

Handful of Options

Like Covid-19 vaccines, antibody drugs were developed rapidly in hopes 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 U.S. government secured billions of dollars in agreements for the therapies. In April, the U.S. canceled a deal for hundreds of thousands of doses containing just one of the two antibodies in the combination, bamlanivimab, due to fears of reduced effectiveness against some variants.

Viruses constantly mutate, and some new strains of the coronavirus have arisen that are less responsive to certain drugs and vaccines. The gamma variant was first detected in Brazil, while the beta variant surfaced in South Africa.

The same resistance phenomenon occurs with antibiotics commonly used to treat bacteria. Like antivirals, antibiotics are often given in combination to defeat resistant pathogens.

In addition to shipments of the combination, the pause affects those of etesevimab alone, which had been sent out to pair with remaining doses of bamlanivimab, according to the statement.

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