New COVID-19 Monoclonal Antibody Treatment Gets FDA Emergency Authorization
By Emma Freer

There’s a new COVID-19 therapeutic on the market that has shown promise in fighting the omicron variant, and state health officials say it’s already in distribution across Texas.

The Food and Drug Administration (FDA) issued an emergency use authorization on Feb. 11 for bebtelovimab, a monoclonal antibody treatment for mild-to-moderate COVID-19 in patients at high risk for severe disease and for whom alternative treatments are not accessible or appropriate. This is welcome news after the most recent surge, fueled by the omicron variant, wiped out Texas’ supply of monoclonal antibody treatments. That left medicine to find new therapeutics that were effective against the new variant and widely available.

The Texas Department of State Health Services (DSHS) received its first allocation of 4,330 courses of bebtelovimab from the federal government on Feb. 14 and quickly began distributing them. Manda Hall, MD, DSHS associate commissioner of community health improvement, says current demand is likely muted because the treatment is so new.

Bebtelovimab is authorized for people aged 12 and older (weighing at least 40 kilograms, or approximately 88 pounds). The 175-milligram intravenous injection should be administered over at least 30 seconds, and the treatment should occur as soon as possible after a positive viral test, either molecular or antigen, and within seven days of symptom onset. This and other guidance is available in a Feb. 12 letter DSHS sent to Texas physicians and other health care professionals.

Bebtelovimab is not authorized for use in patients who:

  • Require an increase in baseline oxygen therapy or respiratory support (or both) due to COVID-19; or
  • Require an increase in baseline oxygen flow rate or respiratory support (or both) due to COVID-19 and are on chronic oxygen or respiratory support (or both) due to an underlying, non-COVID-19-related comorbidity.

DSHS will allocate bebtelovimab in a similar manner as previous monoclonal antibody treatments, free of charge and based on disease burden and geographical distribution. Physicians caring for eligible patients will be able to use the U.S. Department of Health and Human Services’ locator tool to identify an infusion center with availability after sites begin weekly use reporting.

As data supporting the emergency use authorization, FDA cited placebo-controlled clinical trials that found bebtelovimab treatment resulted in quicker symptom resolution, a reduction in viral load, and reduced hospitalization rates, according to FDA’s Feb. 11 news release.

More information can be found in FDA’s fact sheet and FAQ document.

Last Updated On

April 05, 2022

Originally Published On

February 22, 2022

Related Content

Coronavirus

Emma Freer

Reporter

(512) 370-1383
 

Emma Freer is a reporter for Texas Medicine. She previously worked in local news, covering city politics, economic development, and public health. A native Clevelander, she graduated from Columbia Journalism School and the University of St. Andrews.

More stories by Emma Freer