FDA expected to sharply restrict use of monoclonal antibodies made by Lilly, Regeneron

  • Comments
  • Print

The Food and Drug Administration is poised as soon as Monday to restrict two monoclonal antibodies, saying the COVID-19 treatments should not be employed in any states because they are ineffective against the dominant omicron variant, according to two senior administration health officials.

As a result, the Biden administration will pause distribution of the therapies, manufactured by Indianapolis-based Eli Lilly and Co. and Regeneron Pharmaceuticals to the states.

Lilly shares were down 3.5% in early-afternoon trading, to $234.63 each.

“We want to make sure that patients get treatments that are effective, not treatments that don’t work,” said one of the officials, who spoke on the condition of anonymity to describe internal discussions.

The FDA action will involve revising the emergency use authorizations for the monoclonal antibodies. The agency won’t revoke the authorizations in case the treatments become useful against a future coronavirus variant.

The Centers for Disease Control and Prevention has estimated that more than 99 percent of current COVID-19 cases are caused by omicron.

Biden administration officials noted that several therapies remain effective against omicron, including sotrovimab—a monoclonal antibody made by GlaxoSmithKline and Vir Biotechnology—and antiviral pills by Pfizer and by Merck and its partner, Ridgeback Biotherapeutics.

In addition, the use of the antiviral drug remdesivir as an outpatient therapy recently got the green light from regulators. However, some of the treatments, including the Pfizer pill and sotrovimab, are experiencing supply shortages.

The new restrictions on the Regeneron and Lilly drugs are coming as Florida Gov. Ron DeSantis (R) has moved to set up new sites in his state that use the treatments the federal government says are ineffective. DeSantis has said he is not convinced they are ineffective against omicron, and noted they work on cases caused by delta, the variant that previously was dominant.

DeSantis is a foe of vaccine mandates and has implied erroneously the shots might hurt fertility.

In an email last week, DeSantis’s spokeswoman, Christina Pushaw, said a small percentage of cases in Florida are still being caused by delta. She also said lab tests showing the loss of effectiveness by Regeneron and Lilly against the omicron variant are “not conclusive.”

Senior Biden administration officials last week called health officials in several states to urge them to stop using the Regeneron and Lilly drugs.

An official Monday who spoke on the condition of anonymity to describe internal discussions expressed frustration that some governors are still promoting ineffective medications.

“Frankly, at this stage, it’s dangerous that they would do that,” the official said. “It’s beyond irresponsible to use these products that aren’t without their own risks when we know they offer basically zero benefit.”

Last week, a treatment-guidelines committee at the National Institutes of Health discouraged use of the Regeneron and Lilly antibody drugs, saying they are “predicted to have markedly reduced activities” against omicron.

Please enable JavaScript to view this content.

Story Continues Below

Editor's note: You can comment on IBJ stories by signing in to your IBJ account. If you have not registered, please sign up for a free account now. Please note our updated comment policy that will govern how comments are moderated.

3 thoughts on “FDA expected to sharply restrict use of monoclonal antibodies made by Lilly, Regeneron

    1. Please check your facts before posting this misinformation by innuendo. COVID has several variants. One or more are more infectious to young people than others. Also, there were always young people who became infected before the vaccines were developed. Your post might discourage young people from getting vaccinated. No vaccine means one is much more likely to become seriously infected resulting in more hospitalizations and even deaths. Over 90% of the hospitalizations are people who were unvaccinated. I would not want to post anything that might lead young people to have a greater risk of severe illness.

    2. One of my children got COVID long before a vaccine was approved, so, as usual, you’re wrong.

      A better question is why you are allowed to spread misinformation by the IBJ.