Eli Lilly COVID-19 antibody drug shipments paused over variant concerns

U.S. health officials have paused the distribution of two Eli Lilly & Co. COVID-19 monoclonal antibody treatments because of data showing that they aren’t effective against virus variants that are becoming increasingly common across the country.

The Department of Health and Human Services said Friday that it is immediately pausing all distribution of bamlanivimab and etesevimab together, as well as etesevimab alone to be paired with existing supplies of bamlanivimab, in the U.S. until further notice.

Health administrators cited analyses that found that the two antibody treatments together weren’t effective against two variants: the Gamma variant, first identified in Brazil, and the Beta variant, first identified in South Africa.

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These variants account for more than 11% of COVID-19 cases, a share that is growing, according to the Centers for Disease Control and Prevention.

Distribution of the antibody treatments was already paused because of concerns regarding their effectiveness with the variants in at least nine states including Rhode Island, Arizona, California, Florida, Washington and Massachusetts.

Lilly said that the company is working with governments and regulators to ensure antibodies are available to appropriate patients as variants continue to evolve.

The move comes after Lilly in April asked U.S. health regulators to revoke the authorization for use of bamlanivimab alone because of its lack of potency against some strains of the virus.

At the time the drugmaker said it would focus on distributing a drug cocktail containing bamlanivimab and etesevimab, citing studies that it would neutralize more of the variants when given together. The Food and Drug Administration granted the request.

Instead of the two treatments produced by Lilly, the FDA recommends healthcare providers use Regeneron Pharmaceuticals Inc.’s   REGEN-COV, which has been approved for use since last November, and Vir Biotechnology Inc. and GlaxoSmithKline PLC’s sotrovimab, which was approved in May.

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Both monoclonal antibody therapies were approved for the same use as Lilly’s treatments, and U.S. health authorities found that those treatments are likely to work in spite of the two variants.

The move reveals how emerging variants could pose challenges to both treatments and vaccines. The U.S. is racing to vaccinate Americans as more variants, including the highly transmissible Delta variant, gain a foothold in the country.

The Delta strain, which was first identified in India, could become the dominant strain in the U.S. in the coming weeks, according to researchers.

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Monoclonal antibodies are engineered proteins that mimic the immune system’s response to fight off viruses. Lilly’s first treatment, bamlanivimab, was the first to receive emergency-use authorization in November for use in patients with earlier-stage Covid-19 who aren’t hospitalized but are at high risk. In February, the FDA authorized the combination of bamlanivimab with etesevimab, administered together for patients who are at risk of worsening to severe Covid-19, including those with certain medical conditions or who are ages 65 and over.

Meanwhile, Roche Holding AG announced Friday that the FDA has authorized the company’s drug Actemra for treatment of adults and children ages 2 and older who are hospitalized for Covid-19 and are receiving corticosteroids and require oxygen or breathing support.