Multiple area health entities have stopped use of two monoclonal antibody treatments in response to a decision by the U.S. Food and Drug Administration.
The FDA announced Monday afternoon the limitation of use of monoclonal antibody treatments, bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab), to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.
The FDA added in the news release that based on data, because the two treatments are highly unlikely to be active against the COVID omicron variant, the treatments are not authorized for use in the United States or any of its territories at this time.
The FDA did not rule out re-authorization of the two monoclonal antibody treatments.
Because data shows these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the U.S., these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time.
— U.S. FDA (@US_FDA) January 24, 2022
Both treatments were previously allowed to be used under the FDA’s Emergency Use Authorization designation.
The omicron variant is the latest outbreak of COVID worldwide.
The Florida Department of Health said in a news release Monday night that all monoclonal antibody treatment state sites would close until further notice.
As a result of the @US_FDA's abrupt decision to remove the EUAs for two monoclonal antibodies, monoclonal antibody treatment sites will be closed until further notice. Full press release is below. pic.twitter.com/RGeWTPwxCs
— Florida Dept. of Health (@HealthyFla) January 25, 2022
In a statement to WTXL ABC 27 on Tuesday, a spokesperson with the South Georgia Medical Center in Valdosta noted that once the emergency use authorization for the two monoclonal antibody treatments were removed, SGMC removed any stock it had from its inventory and is no longer using the treatments.
According to the National Infusion Center Association, a nonprofit trade association that lists monoclonal antibody treatment locations nationwide, there were a combined eight medical facilities in the area that were confirmed to provide monoclonal antibody treatments.
