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FDA Pauses Authorization for Last Remaining COVID-19 Monoclonal Antibody Treatment

In science and medicine, information is constantly changing and may become out-of-date as new data emerge. All articles and interviews are informational only, should never be considered medical advice, and should never be acted on without review with your health care team.

Bebtelovimab joins the long list of “here and gone” anti- SARS-CoV-2 monoclonal antibodies that are no longer reliably effective in treating COVID-19 due to mutations in the dominant variants of concern. For the past monoclonals such as REGEN-COV or sortovimab, Omicron rendered them ineffective. For bebtelovimab, its Achille’s heel was Omicron subvariants BQ.1 and BQ.1.1, that now account for 57% of all COVID cases in the US. As a result, the FDA just announced that bebtelovimab, the last available antibody used to treat COVID-19, is not currently authorized for emergency use in the US. So it, too, is gone.

For those with chronic lymphocytic leukemia, this is a significant loss as bebtelovimab was a very effective therapy done as a short outpatient infusion and had almost no side effects or drug-drug interactions.

We still have very effective drugs, Paxlovid, and remdisivir. In addition, high titer COVID-19 convalescent plasma is recommended again, but each of these therapies has particular associated hassles and precautions.

As of today, Dec. 1, 2022, we still have EVUSHELD for pre-exposure prophylaxis, but its days are surely numbered as it neutralizes even fewer of the circulating variants of concern than does bebtelovimab.

New therapies are coming, but for now, get boosted (it does help many of us), mask up, and practice all the appropriate mitigation strategies.

Here is the official FDA announcement: FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region

We will get through this winter of our discontent if we are smart and careful.

Stay strong. We are all in this together

Brian Koffman, MDCM (retired) MS Ed (he, him, his)
Co-Founder, Executive VP, and Chief Medical Officer
CLL Society, Inc.