SARS-CoV-2 mAbs Continued to Be Used After FDA Deauthorization

TUESDAY, Aug. 30, 2022 (HealthDay News) — More than 158,000 doses of two anti-severe acute respiratory syndrome coronavirus 2 monoclonal antibodies (mAbs), bamlanivimab-etesevimab and casirivimab-imdevimab, were administered in early 2022, despite deauthorization of their use by the U.S. Food and Drug Administration on Jan. 24, 2022, according to a research letter published online Aug. 29 in JAMA Network Open.

Noting that the omicron variant was determined not to be susceptible to treatment with bamlanivimab-etesevimab and casirivimab-imdevimab, Timothy S. Anderson, M.D., from the Beth Israel Deaconess Medical Center in Boston, and colleagues examined their use after deauthorization. Reporting was examined from Oct. 27, 2021, through June 29, 2022, to identify national trends in use of each mAb product.

The researchers found a peak in administration of bamlanivimab-etesevimab and casirivimab-imdevimab during the week of Dec. 22, 2021, with 91,036 doses reported. Throughout the remainder of the study, use of mAbs declined. After FDA deauthorization on Jan. 24, 2022, both bamlanivimab-etesevimab and casirivimab-imdevimab continued to be administered. After FDA deauthorization, the overall use of these mAbs declined, but in late March 2022, the proportion of COVID-19 cases for which these treatments were used peaked (43 treatments per 1,000 cases). After deauthorization, 158,395 mAb doses were administered, with widespread variability in administration by state; Florida and New York accounted for 24 and 20 percent, respectively.

“Our findings suggest that the use of deauthorized mAb products was widespread, even though patients had a minimal likelihood of benefit,” the authors write. “Whether deauthorized treatments will be covered by payers and whether the FDA will take regulatory action against entities violating its guidance remains unknown.”

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