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The Food and Drug Administration has formally restricted the use of antibody treatments that have lost their once considerable effect to the Omicron variant, pausing a therapy that had been widely adopted, including by people avoiding vaccinations.
Many healthcare systems stopped using antibody treatments weeks ago as Omicron scaled up. And while doctors have welcomed news of additional treatments like antiviral pills, they say the trickle of pills and other treatments are no match for the geyser of new cases.
the FDA said Monday it was limiting emergency use authorizations for antibody treatments Regeneron and Eli Lilly to say infusions should not be used now, with the dominant Omicron variant, which the Centers for Disease Control and Prevention estimated at 99.5 percent of all new cases nationwide.
During an earlier surge caused by the Delta variant, these drugs Regeneron and Lilly were effective in keeping infected people out of hospital if given early enough. As Omicron emerged, it became clear that the treatments would not neutralize the virus, and major health systems, including some in New York, stopped using them in December.
Federal officials paused their use soon after, but were reprimand by Republican governors saying they could still help some patients with the Delta variant. This has become an increasingly fragile position, given the difficulty most physicians have in determining each patient’s variant.
Since then, a monoclonal antibody treatment from GlaxoSmithKline and Vir Biotechnology has remained effective against Omicron, although doctors said it was in short supply. Frontline doctors who stopped using the ineffective treatments in December immediately began looking for replacements as cases soared.
In January, federal authorities began shipping antiviral pills Paxlovid from Pfizer and molnupiravir from Merck. The drugs proved complicated to deliver, given Paxlovid’s interactions with many other drugs and the risks of molnupiravir for patients of childbearing age.
They have also been difficult to find, with doctors saying they have to make dozens of calls to find pills in stock at pharmacies.
Dr Mark Morocco, an emergency physician at the University of California, Los Angeles, said high-risk patients, who are no longer eligible for antibody treatments, were receiving treatment similar to what people were receiving in 2020, including including supplemental oxygen and steroids. As for antiviral pills and effective antibody treatments, he said, supplies are “very hard to come by.”
“In my opinion, these drugs are not really available, basically for us,” Dr. Morocco said.
Despite the lack of efficacy of Regeneron and Eli Lilly products, federal data show nearly 20,000 doses were given to patients in the past week alone, with the highest usage in Florida, Louisiana and Michigan.
The treatments, widely considered safe, can have side effects, including shortness of breath, nausea and vomiting.
Options for early Covid treatment continue to expand. On Friday, the FDA approved the use of remdesivir for outpatients, as researchers found it effective in reducing hospitalizations when used early.
Brii Biosciences announced that its monoclonal antibody works well against Omicron and is under review by the FDA
However, effective new treatments can’t come soon enough, said Dr. Steve Pergam, a professor at the Fred Hutchinson Cancer Research Center who also treats patients.
He said the quantities were so scarce that the first treatments are for leukemia patients at the highest risk of death from Covid. And given the current delays in testing, matching the most-at-risk cancer patients with the handful of treatments is a major undertaking.
“The thing we tell patients is that you have to do everything you can not to get it,” he said, “because it can still be quite dangerous.”
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