Key TakeawaysThe monoclonal antibody bebtelovimab is no longer authorized as a treatment for COVID-19, the FDA said.Bebtelovimab does not appear to hold up against the dominant Omicron subvariants BQ.1 and BQ.1.1.The FDA decision removes the last available monoclonal antibody treatment for COVID-19 from the market, leaving immunocompromised individuals more vulnerable heading into the winter season.

Key Takeaways

The monoclonal antibody bebtelovimab is no longer authorized as a treatment for COVID-19, the FDA said.Bebtelovimab does not appear to hold up against the dominant Omicron subvariants BQ.1 and BQ.1.1.The FDA decision removes the last available monoclonal antibody treatment for COVID-19 from the market, leaving immunocompromised individuals more vulnerable heading into the winter season.

The last remaining COVID-19 monoclonal antibody treatment,bebtelovimab, is no longer authorized for emergency use in the United States, the Food and Drug Administrationannouncedlast week.

Bebtelovimab does not appear to hold up against theOmicron subvariants BQ.1 and BQ.1.1, which make up more than 60% of COVID-19 casesnationallyand are likely to continue gaining prevalence, the FDA said.

Eli Lilly, the manufacturer of bebtelovimab, has stopped distributing the antibody treatment, the FDA said. The U.S. government is keeping its stock of the treatment on-hand, in case it can be useful against future variants.

The evolution of COVID-19has already rendered many monoclonal antibody treatments ineffective. The bebtelovimab news marks the removal of yet another tool from the arsenal to defend against COVID-19.

COVID-19 Treatments: What You Need to Know

“It is not a surprising move. I think it’s a little bit overdue,” Jason Gallagher, PharmD, a clinical professor at Temple University School of Pharmacy and clinical pharmacy specialist in infectious diseases at Temple University Hospital, told Verywell. “We’ve reached the point where the majority of new COVID infections are due to strains that bebtelovimab doesn’t work against, so it was time to pull the plug.”

In a preprint study, researchers reported that Omicron BQ.1.1, BA.4.6, and BA.2.75.2 were all resistant to bebtelovimab. Neutralizing antibody levels were “low to undetectable” against BQ.1.1 four months after boosting.

There were more than 300,000 reported COVID-19 cases in the last week.With the approach of colder winter months, cases are expected to increase. Given the rapid evolution of the virus, future variants could become even more transmissible and evasive of our current treatments.

Fewer Options for Immunocompromised Patients

Bebtelovimab is a single-dose injection given to people who test positive for COVID-19 and are at high risk of developing severe disease. Before it was discontinued, the FDA said bebtelovimab should only be given to people who cannot take antiviral drugs like Paxlovid (nirmatrelvir and ritonavir) or remdesivir.

For people with weakened immune systems, monoclonal antibodies are preferable to antivirals, Gallagher said. Paxlovid, for instance, interacts with many medications that might be essential for immunocompromised people.

“It isn’t that Paxlovid or other antivirals won’t work in them. They certainly can. It’s just the most obvious deficit that patients have is the antibody response from vaccinations. We basically could give that to them as a monoclonal, but now we can’t,” Gallagher said.

CDC Expands List of Groups at Risk for COVID-19

What Other COVID-19 Treatments Are Available Now?

In addition to bebtelovimab, several monoclonal antibodies have already been discontinued because they were shown to fail atneutralizing the dominant Omicron subvariants:

Paxlovid is the primary treatment that is considered to be effective against newer Omicron variants. TheantiviralLagevrio (molnupiravir)is also an oral medication.

A New Study Suggests Paxlovid Could Prevent Long COVID

Remdesivir, sold under the name Veklury, can also slow the disease progression to keep people sick with COVID-19 out of the hospital. But it must be given intravenously over several days, making it an inconvenient option for most people.

Evusheld (tixagevimab plus cilgavimab) is a pre-exposure therapy that gives a boost to people who mount only a weak immune responsefrom vaccination. The treatment is still available, though theFDA warnedlast month that it may not hold up against newer viral variants.

Immunocompromised individuals can also receive COVID-19 convalescent plasma. This treatment became less commonly used after monoclonal antibodies became available, but Gallagher said the medical community may have to consider using them again.

Gallagher said monoclonal antibodies are still worth investing in and manufacturers are working on developing monoclonal antibodies that will better target newer versions of Omicron.

Ask an Expert: Do I Really Need the Bivalent Booster? And Will I Need It Again?

What This Means For YouBeing up to date with your COVID-19 vaccines and booster shots is still the best way to protect yourself against severe disease and death from COVID-19. If you have a medical condition or take a medication that weakens your immune system against COVID-19, speak with your provider about your options for treatment.

What This Means For You

Being up to date with your COVID-19 vaccines and booster shots is still the best way to protect yourself against severe disease and death from COVID-19. If you have a medical condition or take a medication that weakens your immune system against COVID-19, speak with your provider about your options for treatment.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit ourcoronavirus news page.

4 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Centers for Disease Control and Prevention.COVID data tracker: variant proportions.

Planas D, Bruel T, Staropoli I, et al.Resistance of Omicron subvariants BA.2.75.2, BA.4.6 and BQ.1.1 to neutralizing antibodies.bioRxiv. Preprint posted online November 21, 2022. doi:10.1101/2022.11.17.516888

National Institutes of Health.COVID-19 treatment guide: anti-SARS-CoV-2 monoclonal antibodies.

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